FDA Letters in July 2026

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.

FDA posted an approval letter for IC-GREEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050710, NDA 050784, NDA 050711 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PURIXAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205919 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for VERZENIO on 2026-07-20. 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 REZZAYO on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PHEBURANE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216513 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Fil-Bay Import, 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 mkpodplug.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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 posted an approval letter for STELARA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LIPFENDRA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220848 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ENDOMETRIN on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022057 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TEGRETOL, TEGRETOL-XR on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016608, NDA 018927, NDA 020234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to San Jorge 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 Island Kinetics, Inc. d.b.a. CoValence Laboratories concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, 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 RETEVMO on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213246, NDA 218160 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SEROSTIM, SEROSTIM LQ on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 020604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for REVTORPYK on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219908 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to LDNN 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 issued a warning letter to AAL Trading 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 Friend’s Stable and Orchard, Inc. concerning Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated. 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 ZYOGREEN on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218579 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KEYTRUDA on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TUXARIN ER on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206323 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KEYTRUDA QLEX on 2026-07-13. 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 SARCLISA ESCENA on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761445 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XELSTRYM on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215401 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PADCEV on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761137 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to BioMylz Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, 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 issued a warning letter to Almon Healthcare Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of 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 Shimoga Chemicals concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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 LUMVOA on 2026-07-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761530 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SODIUM BICARBONATE on 2026-07-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220790 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to indejuicevapestore.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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 Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, 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 ejuicedemand.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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'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's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events. 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 VasoCorp, Inc. concerning Unapproved New Drugs/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 posted an approval letter for INBRIJA on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TRUTAKNA on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761486 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RYALTRIS on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211746 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SPORANOX on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020083, NDA 020657 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Beauty Store 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 Spa De Soleil, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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 issued a warning letter to IJAJ Group Inc DBA Sanz Wholesale Foods 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 LEVOTHYROXINE SODIUM on 2026-07-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ELOCON on 2026-07-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019625, NDA 019543, NDA 019796 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Specialty Health Products CO, LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, 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 RYZUMVI on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217064 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZYRTEC ALLERGY on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KISQALI on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209092 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for FETROJA on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220874 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for KISQALI FEMARA CO-PACK (COPACKAGED) on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209935 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Waves and Wine, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA posted an approval letter for TRUXIMA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761088 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ONAPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for QSYMIA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OPZELURA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for STRATTERA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted a tentative approval letter for ABANTA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221024 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for MAYZENT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209884 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for COPAXONE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020622 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for HEPZATO on 2026-07-02. 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 SOLIRIS on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ANZUPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XELJANZ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for COLUMVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for SOTYKTU on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ISTURISA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212801 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for EPYSQLI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for CIBINQO on 2026-07-02. 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 BKEMV on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for OLUMIANT on 2026-07-02. 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 LEQSELVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for RINVOQ, RINVOQ LQ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211675, NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for PARLODEL on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ERLEADA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for ZORYVE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for LITFULO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215830 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA posted an approval letter for TASCENSO ODT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to International Medication Systems Limited 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 issued a warning letter to eliquidflavourconcentrates.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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 Good Stuff Cacao concerning New Drug/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 snusblast.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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 Piquin Y Sabores Distributors 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.