FDA Letters Issued in May 2026

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 an approval letter for JYLAMVO on 2026-05-29. The source metadata identifies NDA 212479 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMFINZI on 2026-05-29. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for METHOTREXATE SODIUM on 2026-05-29. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HEPZATO on 2026-05-29. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TREMFYA on 2026-05-29. The source metadata identifies BLA 761061 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FERAHEME on 2026-05-29. The source metadata identifies NDA 022180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COLUMVI on 2026-05-29. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DECNUPAZ on 2026-05-29. The source metadata identifies BLA 761460 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRUQAP on 2026-05-29. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMPLANON, NEXPLANON on 2026-05-29. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XATMEP on 2026-05-29. The source metadata identifies NDA 208400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Macau-Union Pharmaceutical Limited concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, 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 Jubilant HollisterStier General Partnership 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 Medline 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, 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 Jose M. Carpio, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, 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 an approval letter for FINTEPLA on 2026-05-27. The source metadata identifies NDA 212102 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NULIBRY on 2026-05-27. The source metadata identifies NDA 214018 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KOSELUGO on 2026-05-27. The source metadata identifies NDA 213756, NDA 219943 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CRESTOR on 2026-05-27. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DATROWAY on 2026-05-27. The source metadata identifies BLA 761394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TOFIDENCE on 2026-05-27. The source metadata identifies BLA 761354 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for UPTRAVI on 2026-05-27. The source metadata identifies NDA 207947, NDA 214275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Pharmathen International S.A. concerning CGMP/Active Pharmaceutical Ingredient (API)/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 Linemaster Switch Corporation concerning CGMP/QSR/Drug/Medical Devices/Adulterated. Deterministic source-metadata screening identifies discussion of 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 an approval letter for VENCLEXTA on 2026-05-26. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LINZESS on 2026-05-26. The source metadata identifies NDA 202811 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NYVEPRIA on 2026-05-26. The source metadata identifies BLA 761111 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219257 on 2026-05-26. The source metadata identifies ANDA 219257 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CANAGLIFLOZIN on 2026-05-26. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CLONAZEPAM on 2026-05-26. The source metadata identifies ANDA 216988 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VARITHENA on 2026-05-26. The source metadata identifies NDA 205098 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for THALIDOMIDE on 2026-05-26. The source metadata identifies ANDA 213267 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SERNIVO on 2026-05-26. The source metadata identifies NDA 208079 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-05-26. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HEPCLUDEX on 2026-05-26. The source metadata identifies BLA 761468 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-05-26. The source metadata identifies ANDA 210672 as an original application. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued a warning letter to Blue Horizon International, LLC concerning Unapproved New Drugs/Unlicensed Biological Product Violations. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Pamex Foods Incorporated 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 an approval letter for DIFFERIN EPIDUO, DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) on 2026-05-22. The source metadata identifies NDA 220736 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to ZIIP, Inc. 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 issued a warning letter to Laboratorios Jaloma S.A. de C.V. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of 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 Aeroflex Industria de Aerosol Ltda. concerning Refusal to Provide Access to and Copying of Records. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for RINVOQ LQ on 2026-05-21. The source metadata identifies NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-05-21. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TYENNE on 2026-05-21. The source metadata identifies BLA 761449 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XYZAL ALLERGY 24HR on 2026-05-21. The source metadata identifies NDA 209089 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TYENNE on 2026-05-21. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHOLBAM on 2026-05-21. The source metadata identifies NDA 205750 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REMERON on 2026-05-21. The source metadata identifies NDA 020415 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Alchymars ICM SM Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, 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 BMC Medical Co., Ltd. concerning CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, 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 Aversa's Italian Bakery concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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 issued a warning letter to Golden Dakota Farms LLC concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of 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 issued a warning letter to 3B Medical, Inc. dba Reach Health, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic source-metadata screening identifies discussion of 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 an approval letter for ZYNYZ on 2026-05-19. The source metadata identifies BLA 761334 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PHESGO on 2026-05-19. The source metadata identifies BLA 761170 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HERCEPTIN, HERCEPTIN HYLECTA on 2026-05-19. The source metadata identifies BLA 103792, BLA 761106 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN on 2026-05-19. The source metadata identifies NDA 203049 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENHERTU on 2026-05-19. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CREXONT on 2026-05-19. The source metadata identifies NDA 217186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TECENTRIQ on 2026-05-19. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ONAPGO on 2026-05-19. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to vapetrinity.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, 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 HealthPartners Neuroscience Center Research and Innovation concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of Data integrity and records, 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 snusguys.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, 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 npouches.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, 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 pouchline.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, 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 Skytron, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic source-metadata 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 pouchew.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, 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 Smoker Business concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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 vapenovaco.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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 gethyppe.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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 an approval letter for MAVENCLAD on 2026-05-18. The source metadata identifies NDA 022561 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRIMBOW on 2026-05-18. The source metadata identifies NDA 219622 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMMGOLIS, IMMGOLIS INTRI on 2026-05-18. The source metadata identifies BLA 761452 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to GSC Products, LLC concerning Nonprescription/OTC. 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 Sato Pharmaceutical Co., Ltd. concerning CGMP/Drugs/Adulterated/OTC. Deterministic source-metadata screening identifies discussion of 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 Aja Health and Wellness Inc. concerning Nonprescription/OTC. No controlled compliance theme met the deterministic text-matching threshold; 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 issued an approval letter for INQOVI on 2026-05-15. The source metadata identifies NDA 212576 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for YONSA on 2026-05-15. The source metadata identifies NDA 210308 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUZYRA on 2026-05-15. The source metadata identifies NDA 209816, NDA 209817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BEQALZI on 2026-05-15. The source metadata identifies NDA 220711 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to vape4sale.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 Meta Labs Pharmaceuticals, LLC concerning Dietary Supplement/New Drug/Misbranded. Deterministic source-metadata 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 City Market, 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 issued a warning letter to La Crema De Rebeca concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata 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 Bharat Overseas 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 GC America, Inc. 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 PolleyMed, LLC concerning Nonprescription/OTC. 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 Lus Essentials 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 Bushman Organic Farms, 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 an approval letter for KEYTRUDA QLEX on 2026-05-13. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-05-13. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TECENTRIQ HYBREZA on 2026-05-13. The source metadata identifies BLA 761347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CARDIOGEN-82 on 2026-05-13. The source metadata identifies NDA 019414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZERBAXA on 2026-05-13. The source metadata identifies NDA 206829 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPDIVO on 2026-05-13. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZIEXTENZO on 2026-05-13. The source metadata identifies BLA 761045 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WEZLANA on 2026-05-13. The source metadata identifies BLA 761285, BLA 761331 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PYRIDOSTIGMINE BROMIDE on 2026-05-13. The source metadata identifies NDA 217604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TECENTRIQ on 2026-05-13. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-13. The source metadata identifies NDA 016730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPDIVO QVANTIG on 2026-05-13. The source metadata identifies BLA 761381 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DIOVAN on 2026-05-12. The source metadata identifies NDA 021283 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENNUMO on 2026-05-12. The source metadata identifies BLA 761147 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Dough-To-Go, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic source-metadata screening identifies discussion of 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 Flax & More Corporation concerning CGMP/Dietary Supplement/Adulterated. 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 issued a warning letter to Fagron BV concerning Compounding Pharmacy/Adulterated Drug Products. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for VYVGART, VYVGART HYTRULO on 2026-05-11. The source metadata identifies BLA 761195, BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SDAMLO on 2026-05-11. The source metadata identifies NDA 219531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ADEMPAS on 2026-05-11. The source metadata identifies NDA 204819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LEVO-T on 2026-05-11. The source metadata identifies NDA 021342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NURTEC ODT on 2026-05-11. The source metadata identifies NDA 212728 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRILINTA on 2026-05-11. The source metadata identifies NDA 022433 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OCREVUS on 2026-05-11. The source metadata identifies BLA 761053 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYPREXA RELPREVV on 2026-05-11. The source metadata identifies NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MEKINIST on 2026-05-11. The source metadata identifies NDA 204114 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BIZENGRI on 2026-05-11. The source metadata identifies BLA 761352 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALTACE on 2026-05-11. The source metadata identifies NDA 019901 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SILIQ on 2026-05-11. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LUPRON on 2026-05-08. The source metadata identifies NDA 019010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZOLADEX on 2026-05-08. The source metadata identifies NDA 020578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELIGARD KIT on 2026-05-08. The source metadata identifies NDA 021343, NDA 021379, NDA 021488, NDA 021731 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VANTAS on 2026-05-08. The source metadata identifies NDA 021732 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZOLADEX on 2026-05-08. The source metadata identifies NDA 019726, NDA 020515 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TECVAYLI, TALVEY on 2026-05-08. The source metadata identifies BLA 761291, BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to ct-riecig.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 waterbedsnstuff.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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 an approval letter for AUVELITY on 2026-05-06. The source metadata identifies NDA 215430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on 2026-05-05. The source metadata identifies NDA 219804 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REXULTI on 2026-05-04. The source metadata identifies NDA 205422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LAZCLUZE on 2026-05-04. The source metadata identifies NDA 219008 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NIZORAL ANTI-DANDRUFF on 2026-05-04. The source metadata identifies NDA 020310 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CARAC on 2026-05-04. The source metadata identifies NDA 020985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PRECEDEX on 2026-05-04. The source metadata identifies NDA 021038 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VEPPANU on 2026-05-04. The source metadata identifies NDA 219835 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ATONCY on 2026-05-04. The source metadata identifies NDA 220320 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-04. The source metadata identifies NDA 020201 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for JAKAFI XR on 2026-05-04. The source metadata identifies NDA 217180 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XPOVIO on 2026-05-04. The source metadata identifies NDA 212306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-05-04. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ADVIL, JUNIOR STRENGTH ADVIL on 2026-05-04. The source metadata identifies NDA 020944 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEXMEDETOMIDINE HYDROCHLORIDE on 2026-05-04. The source metadata identifies NDA 206628 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EVDI on 2026-05-04. The source metadata identifies NDA 220837 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Naseem A. Jaffrani, M.D. concerning Clinical Investigator. Deterministic source-metadata 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 IDO Pharm Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Naveh Pharma LTD/Bigdam Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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 an approval letter for VANFLYTA on 2026-05-01. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BREZTRI AEROSPHERE on 2026-05-01. The source metadata identifies NDA 212122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUPLAZID on 2026-05-01. The source metadata identifies NDA 207318, NDA 210793 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LANGLARA on 2026-05-01. The source metadata identifies BLA 761412 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SYMBICORT AEROSPHERE on 2026-05-01. The source metadata identifies NDA 216579 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENHERTU on 2026-05-01. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for THALOMID on 2026-05-01. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REVLIMID on 2026-05-01. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NGENLA on 2026-05-01. The source metadata identifies BLA 761184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for POMALYST on 2026-05-01. The source metadata identifies NDA 204026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd. concerning CGMP/API/Adulterated and Misbranded Drugs. Deterministic source-metadata 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 issued a warning letter to kadobarofficial.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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 swisschlz.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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.