FDA Letters in August 2026

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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