FDA Letters in 2026

FDA posted an approval letter for ROZLYTREK on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212725, NDA 218550 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NDA 219617 on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219617 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CARBON DIOXIDE, USP on 2026-10-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 222000 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PIFELTRO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CAMZYOS on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214998 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019631 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZEPZELCA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XENICAL on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020766 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AVTOZMA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DELSTRIGO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210807 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EYDENZELT on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to The Platinum Healthcare LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Bioactive Services USA, LLC / Herstat Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to OrganiCare, LLC / OrganiCare Nature’s Science, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Walmart, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Aidance Scientific, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Graceful Touch, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to RoyceDerm LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Terramed concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for MATULANE on 2026-09-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AVTOZMA on 2026-09-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761498 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BENDAMUSTINE HYDROCHLORIDE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219014 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DEGEVMA on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761481 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OLUMIANT on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YUSIMRY on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761216 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NDA 221109 on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221109 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CLARITIN, CLARITIN HIVES RELIEF on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019658 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RUXIENCE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761103 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EMCITATE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220963 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JUVMO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220415 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RIABNI on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761140 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ATEBRIOZ on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221198 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZUEINO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218379 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022485 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GAZYVA on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125486 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for APIXABAN on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220446 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for WELIREG on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VALIUM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 013263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PYRUKYND, AQVESME on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LENVIMA on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206947 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DAPZURA RT, DAPTOMYCIN IN 0.9% SODIUM CHLORIDE on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213645 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JORNAY PM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209311 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LYRFIGTU on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220425 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PAXIL, PAXIL CR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020031, NDA 020710, NDA 020936 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TEPEZZA on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761143 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CRESTOR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ONSWIK on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761408 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to sfshoply.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for METHOTREXATE SODIUM on 2026-09-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Cheap Medicine Shop/www.cheapmedicineshop.com concerning Unapproved New Drugs/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for PREXXARTAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NUBEQA on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212099 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SCEMBLIX on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LUMRYZ on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214755 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CLAFORAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050547 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TYVASO DPI on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214324 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Online Generic Medicine/www.onlinegenericmedicine.com concerning Unapproved New Drug/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Neogen Corporation concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Sciarra Aeromed, Inc. concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for VERZENIO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for WINREVAIR on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for INLURIYO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218881 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SOHONOS on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215559 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AQNEURSA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ANNOVERA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Fresenius Kabi USA LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Unilam Co., LTD concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Medical device quality and reporting, Quality systems and CAPA, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for SPRAVATO on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IBTROZI on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219713 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AMBELVIST on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219627 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EMPAGLIFLOZIN on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220758 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TRUQAP on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZORTRESS on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KERENDIA on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215341 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Babikian Healthcare Products CJSC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Curia New York, Inc. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Bentley Laboratories LLC concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for JYNARQUE on 2026-09-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204441 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GARZULYS on 2026-09-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IMDELLTRA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761344 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EVRYSDI on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213535, NDA 219285 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PIXCLARA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218592 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KYBELLA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BEXLUTRY on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218525 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JOENJA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217759 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ISEMBYLD on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761463 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TAGRISSO on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208065 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Celmade concerning Review of Website/Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for ESTROGEL on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZITUVIMET XR on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to NexCell Scientific Inc concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AMELUZ on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208081 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HYRNUO on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219972 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ETCAMAH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220359 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BYOOVIZ on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OZEMPIC on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to kdc/one Chatsworth, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for POMALIDOMIDE on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210245 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ETOPOPHOS PRESERVATIVE FREE on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020457 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CIBINQO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ALENDRONATE SODIUM on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214523 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for THALOMID on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FYARRO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213312 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for SHEUR on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217650 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AVTOZMA on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761498 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for RELUGOLIX on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219913 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AVTOZMA on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZANVASTRO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220210 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Bausch & Lomb Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for OMCAZIO on 2026-09-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220613 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DUPIXENT on 2026-09-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BAVENCIO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761049 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PENPULIMAB-KCQX on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761258 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CEFAZOLIN IN DEXTROSE on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207131 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LIBTAYO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761097 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YERVOY on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BYOOVIZ on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IMFINZI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KRAZATI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LOPRESSOR on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218698 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BESREMI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LOQTORZI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761240 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BACTOCILL IN PLASTIC CONTAINER on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050640 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for UNLOXCYT on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761297 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IMJUDO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761289 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866, NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MIMRYLO on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220605 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for STELARA on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YUSIMRY on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761216 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CALCIUM GLUCONATE IN SODIUM CHLORIDE on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219037 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HEMANGEOL on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205410 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BESREMI on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Star Ocean Wholesale Foods, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to O.N. Diagnostics, LLC concerning Medical Device Reporting/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Happy Farm Botanicals, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for BIXLENVO on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221104 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VOBRIG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213225 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RASONQUE on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220910 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LISRAYA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220106 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IMAAVY on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OZEMPIC on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215973 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ULTRATAG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019981 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NITROUS OXIDE, USP on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221892 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GATTEX KIT on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203441 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Tipical Latin Food, Corp. DBA La Pradera concerning CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TEVIMBRA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TIVICAY, TIVICAY PD on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204790, NDA 213983 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Stephen J. Fallon, Ph.D. concerning Bioresearch Monitoring Program/Institutional Review Board (IRB). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Union Trade Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Jabil Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Andrighetto Produce Inc dba Shasta Produce Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-08-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215700 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for NDA 218328 on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218328 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BENLYSTA on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761043, BLA 125370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Fresenius Medical Care AG & Co. KGaA concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Advance-Esthetic LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SCEMBLIX on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Peptide Partners LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to BioDrive, Inc. concerning Dietary Supplement/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Royal Peptides LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Peak Performance Peptides concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to TXP Innovations LLC dba Tex Peptides concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to NuScience Peptides LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for YESAFILI on 2026-08-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761274 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OGSIVEO on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TAKHZYRO on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZELBORAF on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202429 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for COTELLIC on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206192 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EMPAVELI on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215014 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Lion Street Medical, d/b/a Pensar Medical LLC concerning Medical Device Reporting/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Raaw Energy LLC concerning Adulterated Animal Foods/Misbranded. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for ZAVZPRET on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216386 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PASATRU on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761508 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017584 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DULOXETINE HYDROCHLORIDE on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219131 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LEQVIO on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to South Asian Food Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for AVAPRO on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TYZAVAN on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BARACLUDE on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021797, NDA 021798 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SUBOXONE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022410 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IQIRVO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218860 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SODIUM BICARBONATE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218524 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ALECENSA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KRYSTEXXA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LEROCHOL on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761427 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZUBSOLV on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204242 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JASCAYD on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SAPHNELO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761123 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YESINTEK on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761406 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to B&P Mutual Corp concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Shoolin Pharma Chem LLP concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Binh Minh Tofu concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to PReye, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Reliance Life Sciences Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for INJECTAFER on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203565 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZENBEXUS on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221075 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TAUKLARIFY on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220496 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BIKTARVY on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VASCEPA on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202057 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Importaciones La Bufa LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for GLUMETZA on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021748 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RIOMET ER on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212595 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XIGDUO XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205649 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ABSORICA, ABSORICA LD on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KAZANO on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KOMBIGLYZE XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200678 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JENTADUETO, SYNJARDY, JENTADUETO XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201281, NDA 206111, NDA 208026, NDA 208658, NDA 212614 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZITUVIMET, ZITUVIMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216743, NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FORTAMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021574 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for INVOKAMET, INVOKAMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204353, NDA 205879 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JANUMET, JANUMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022044, NDA 202270 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SEGLUROMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ACTOPLUS MET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021842 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to R3 Medical Companies concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for DUREZOL on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022212 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HEPZATO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RIMACTANE on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050429 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OPDIVO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for WINREVAIR on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Suretec Innovations, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated and Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Eugia Pharma Specialities Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Bo Wah Enterprises Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Auriga Research Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to K.C. Pharmaceuticals, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for POTASSIUM CHLORIDE, POKONZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208019 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PYRUKYND, AQVESME on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XOFLUZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210854 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MEROPENEM on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215212 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SERNIVO on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208079 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TRYVIO on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217686 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for INPEFA on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216203 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XOLAIR on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103976 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a warning letter to Safrel Pharmaceuticals LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Pine Pharmaceuticals, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to giantnic.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to mikuvape.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for ADEMPAS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ORZEYFUL on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220860 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TYMLOS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KEFLEX on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050405 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BONSITY on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YORVIPATH on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216490 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TERIPARATIDE on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218771 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NEULASTA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125031 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for YUFLYMA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761219 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FORTEO on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021318 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Viva Raw LLC concerning Adulterated Animal Foods/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Quantum Star LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for HERNEXEOS on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KEYTRUDA QLEX on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PLUVICTO on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215833 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZIMRIXBY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761376 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for MEZOFY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211448 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HERNEXEOS on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LYNOZYFIC on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Mesquite Gourmet LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma concerning Animal Drugs/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to American Pharma Mfg. Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for FUROSCIX, FUROSCIX READYFLOW (AUTOINJECTOR) on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209988 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CELLCEPT on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050722, NDA 050723, NDA 050758, NDA 050759 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for Ruxolitinib on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219660 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to H2 BEV, LLC and H2 RENU, INC concerning Acidified Foods/Emergency Permit Control/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to FairyGene, Inc. concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for QLONILIK on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221094 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AIR on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221805 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MYFORTIC on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050791 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MYHIBBIN on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216482 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VEKLURY on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214787 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GLYCOPHOS on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220381 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GWYN LO on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219990 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Lico Industries, LLC., d.b.a. American Towelette Company concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to DeJong Family Dairy, LLC concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for GADAVIST on 2026-07-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201277 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HETLIOZ on 2026-07-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AVAPRO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GARZULYS on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LYTENAVA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761320 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DYNA-HEX 2 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for DYNA-HEX 4 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for REZDIFFRA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BREXAFEMME on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SIMTRIYO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218145 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for IDKIT:HP on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021314 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZIAC on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XTANDI on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203415, NDA 213674 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NORVIR on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022417, NDA 209512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MACRILEN on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TYRUKO on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761322 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KALETRA on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021906, NDA 021251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Maria E. De La Torre Silva, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Vargas Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Woodbine Products Company Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JIDEYTRO on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220185 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for REVLIMID on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CHILDREN'S MOTRIN, MOTRIN IB on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NEURACEQ on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for CANAGLIFLOZIN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210451 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Nipro Renal Solutions USA, Corporation concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding, Medical device quality and reporting. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Dabur India Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Thomas Brunner Hygiene GmbH concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Wilson Livestock concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for CAMCEVI ETM on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219745 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ACANYA, ONEXTON on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Eherbs Imports, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to ABS Corporation concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217769 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for JAKAFI, JAKAFI XR on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202192, NDA 217180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 220197 on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218016 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FOSTAMATINIB DISODIUM on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217329 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VASOPRESSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ROMIDEPSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219099 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219165 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for SCOMARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for INREBIC on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VONJO on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217076 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for RUXOLITINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OJJAARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212572 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VENETOCLAX on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214733 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218722 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for UBROGEPANT on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Ohom Padmaavathii, LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA posted a tentative approval letter for UBROGEPANT on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for LAROTRECTINIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for TIVOZANIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 220143 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for CEFTRIAXONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 220724 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220724 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 219413 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219413 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for PEMIGATINIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EPINEPHRINE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220562 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SUBVENITE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218879 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZOLPIDEM TARTRATE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220717 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for AUGMENTIN '125', AUGMENTIN '250', AUGMENTIN '200' on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050575, NDA 050726, NDA 050785, NDA 050597, NDA 050720, NDA 050755, NDA 050725, NDA 050564 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GALLIUM GA 68 GOZETOTIDE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219189 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TRAMADOL HYDROCHLORIDE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219647 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 220866 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220866 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ADRENALIN on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204640 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ANDA 219346 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219346 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OGSIVEO on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for EDARAVONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Koven Technologies, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Quality systems and CAPA, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA posted an approval letter for LEQEMBI IQLIK on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761375 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FABHALTA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218276 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for BUPRENORPHINE HYDROCHLORIDE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 090279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ARGATROBAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201811 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CHILDREN'S ZYRTEC HIVES, CHILDREN'S ZYRTEC ALLERGY on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for NEUPOGEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103353 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for GLEEVEC on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ILUMYA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761067 as a supplement. Review the exact FDA letter for the approved conditions and labeling.