FDA Letters in September 2026

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.