FDA Letters Issued in March 2026

FDA issued an approval letter for LICART on 2026-03-31. The source metadata identifies NDA 206976 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPKINLY on 2026-03-31. The source metadata identifies BLA 761324 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CARDENE, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER on 2026-03-31. The source metadata identifies NDA 019734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYNYZ on 2026-03-31. 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 PONLIMSI on 2026-03-31. The source metadata identifies BLA 761385 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALLI on 2026-03-31. The source metadata identifies NDA 021887 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOCINVEZ on 2026-03-31. The source metadata identifies NDA 216686 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPINEPHRINE on 2026-03-31. The source metadata identifies NDA 220626 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEJULA on 2026-03-31. The source metadata identifies NDA 214876 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BYOOVIZ on 2026-03-31. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SPINRAZA on 2026-03-31. The source metadata identifies NDA 209531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAYBUE on 2026-03-31. The source metadata identifies NDA 217026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AWIQLI FLEXTOUCH on 2026-03-31. The source metadata identifies BLA 761326 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALYFTREK on 2026-03-31. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Zap Expo Center Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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 PekCura Labs concerning Unapproved New Drugs Sold Over the Internet. 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 Gram Peptides concerning Unapproved New Drugs Sold Over the Internet. 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 Global Tobacco, LLC 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 FormPour concerning Unapproved New Drugs Sold Over the Internet. 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 Guangzhou Huli Technology Co., Ltd. dba Fantasy Face concerning Unapproved New Drugs Sold Over the Internet. 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 Lovega LLC dba Pink Pony Peptides concerning Unapproved New Drugs Sold Over the Internet. 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 Mile High Compounds LLC concerning Unapproved New Drugs Sold Over the Internet. 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 Prime Sciences concerning Unapproved New Drugs Sold Over the Internet. 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 CLEOCIN PHOSPHATE on 2026-03-30. The source metadata identifies NDA 050441 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MEKINIST on 2026-03-30. The source metadata identifies NDA 204114, NDA 217513 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TAFINLAR on 2026-03-30. The source metadata identifies NDA 202806, NDA 217514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BKEMV on 2026-03-30. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NEFFY on 2026-03-30. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-03-30. The source metadata identifies NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CLEOCIN HYDROCHLORIDE on 2026-03-30. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KADCYLA on 2026-03-30. The source metadata identifies BLA 125427 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to DO&CO Aktiengesellschaft/DO&CO, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Food safety and supplier verification, 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 Intas Pharmaceuticals Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Quality systems and CAPA, Manufacturing and CGMP controls, 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 XARELTO on 2026-03-27. The source metadata identifies NDA 022406, NDA 215859 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KRAZATI on 2026-03-27. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MARINOL on 2026-03-27. The source metadata identifies NDA 018651 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LIFYORLI (COPACKAGED) on 2026-03-27. The source metadata identifies NDA 220641 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELREXFIO on 2026-03-27. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WINREVAIR on 2026-03-27. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-03-27. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RINGER'S IN PLASTIC CONTAINER on 2026-03-27. The source metadata identifies NDA 018251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Ehsan Sadri, 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 buydeltas.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 a warning letter to Baja Fresko Distributors 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 J&B Food Consulting 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 Eaglelionton Int'l Trading Co 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 Henan Lvyuan Pharmaceutical Co. Ltd. concerning CGMP/API/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 Xeomin on 2026-03-25. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AK-FLUOR 10%, AK-FLUOR 25% on 2026-03-25. The source metadata identifies NDA 022186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Medline Industries, LP 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 MALARONE, MALARONE PEDIATRIC on 2026-03-24. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KETALAR on 2026-03-24. The source metadata identifies NDA 016812 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPUVIZ on 2026-03-23. The source metadata identifies BLA 761350 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TWINJECT, ADRENACLICK on 2026-03-23. The source metadata identifies NDA 020800 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CREXONT on 2026-03-23. 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 RYTARY on 2026-03-23. The source metadata identifies NDA 203312 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SINEMET CR on 2026-03-23. The source metadata identifies NDA 019856 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VYALEV on 2026-03-23. The source metadata identifies NDA 216962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MEPRON on 2026-03-23. The source metadata identifies NDA 020500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DESOGESTREL AND ETHINYL ESTRADIOL on 2026-03-23. The source metadata identifies ANDA 219761 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DUOPA on 2026-03-23. The source metadata identifies NDA 203952 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLAVALTA on 2026-03-23. The source metadata identifies NDA 216564 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SINEMET on 2026-03-23. The source metadata identifies NDA 017555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPIPEN, EPIPEN JR., EPIPEN E Z PEN on 2026-03-23. The source metadata identifies NDA 019430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DHIVY on 2026-03-23. The source metadata identifies NDA 214869 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for KITPROZY on 2026-03-23. The source metadata identifies NDA 220712 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STALEVO 50, STALEVO 100, STALEVO 150 on 2026-03-23. The source metadata identifies NDA 021485 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMCIVREE on 2026-03-23. The source metadata identifies NDA 213793 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-03-23. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPDIVO on 2026-03-23. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Xiamen Kang Zhongyuan Biotechnology Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Data integrity and records, 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 issued an approval letter for FLUTICASONE PROPIONATE on 2026-03-20. The source metadata identifies ANDA 219602 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OJJAARA on 2026-03-20. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SKYRIZI on 2026-03-20. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INREBIC on 2026-03-20. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XTORO on 2026-03-20. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IOPIDINE on 2026-03-20. The source metadata identifies NDA 019779 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BAL on 2026-03-20. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SABRIL on 2026-03-20. The source metadata identifies NDA 020427, NDA 022006 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220327 on 2026-03-20. The source metadata identifies ANDA 220327 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IOPIDINE on 2026-03-20. The source metadata identifies NDA 020258 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VONJO on 2026-03-20. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for POLIVY on 2026-03-20. The source metadata identifies BLA 761121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ERDAFITINIB on 2026-03-20. The source metadata identifies ANDA 218578 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XTORO on 2026-03-20. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROSCAR on 2026-03-20. The source metadata identifies NDA 020180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Nupack Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of 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 matesbrand.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 a warning letter to RC Outsourcing, LLC 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 ORKAMBI on 2026-03-19. The source metadata identifies NDA 206038, NDA 211358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LYNAVOY on 2026-03-19. The source metadata identifies NDA 220295 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALYFTREK on 2026-03-19. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NURTEC ODT on 2026-03-19. 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 GAMIFANT on 2026-03-19. The source metadata identifies BLA 761107 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KALYDECO on 2026-03-19. The source metadata identifies NDA 203188, NDA 207925 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ICOTYDE on 2026-03-19. The source metadata identifies NDA 220149 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for MACITENTAN on 2026-03-19. The source metadata identifies ANDA 211000 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COMBIGAN on 2026-03-19. The source metadata identifies NDA 021398 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for AFATINIB on 2026-03-19. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRIKAFTA (COPACKAGED) on 2026-03-19. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Shang Hao Jia, 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 Yangzhou H&R Plastic Daily Chemical Co., Ltd. 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 Schlechter Farms Inc. concerning CGMP/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 issued a warning letter to 4U Health concerning Premarket Approval/Adulterated. 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's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. 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 SOLIQUA 100/33 on 2026-03-16. The source metadata identifies BLA 208673 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for METHOTREXATE on 2026-03-16. The source metadata identifies NDA 214121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COSENTYX on 2026-03-16. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VENOFER on 2026-03-16. The source metadata identifies NDA 021135 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ADLYXIN on 2026-03-16. The source metadata identifies BLA 208471 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SUNLENCA on 2026-03-16. The source metadata identifies NDA 215973, NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PALYNZIQ on 2026-03-16. The source metadata identifies BLA 761079 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MEDICAL AIR, USP on 2026-03-16. The source metadata identifies NDA 221337 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRULICITY on 2026-03-16. The source metadata identifies BLA 125469 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Microbiological Testing & Consulting, LLC concerning CGMP/Finished Pharmaceuticals/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 issued a warning letter to ImmunityBio, Inc. concerning False & Misleading Claims/Misbranded. Deterministic full-text screening identifies discussion of 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 an approval letter for LANSOPRAZOLE on 2026-03-12. The source metadata identifies NDA 208025 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALEVE on 2026-03-12. The source metadata identifies NDA 020204 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OGSIVEO on 2026-03-12. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QUILLICHEW ER on 2026-03-12. The source metadata identifies NDA 207960 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARCALYST on 2026-03-12. The source metadata identifies BLA 125249 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OZURDEX on 2026-03-12. The source metadata identifies NDA 022315 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for APHEXDA on 2026-03-12. The source metadata identifies NDA 217159 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DOXIL (LIPOSOMAL) on 2026-03-12. The source metadata identifies NDA 050718 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KARBINAL ER on 2026-03-12. The source metadata identifies NDA 022556 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OMEPRAZOLE on 2026-03-12. The source metadata identifies NDA 209400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Patcos Cosmetics Pvt. Ltd. concerning Finished Drug Products/Adulterated. 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 Adnan Dahdul, MD concerning Clinical Investigator/BIMO. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, 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 ISA Produce Corporation concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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 OraLabs, 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. 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 Flowchem Pharma Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-03-10. The source metadata identifies NDA 016733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QUILLIVANT XR on 2026-03-10. The source metadata identifies NDA 202100 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TROKENDI XR on 2026-03-09. The source metadata identifies NDA 201635 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TOPAMAX, TOPAMAX SPRINKLE on 2026-03-09. The source metadata identifies NDA 020505, NDA 020844 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XELJANZ, XELJANZ XR on 2026-03-09. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEFLEX on 2026-03-09. The source metadata identifies NDA 050406 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TALVEY on 2026-03-09. The source metadata identifies BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TECVAYLI on 2026-03-09. The source metadata identifies BLA 761291 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XYZAL ALLERGY 24HR on 2026-03-09. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOTYKTU on 2026-03-09. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QSYMIA on 2026-03-09. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SKYRIZI on 2026-03-09. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPRONTIA on 2026-03-09. The source metadata identifies NDA 214679 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SANDIMMUNE on 2026-03-09. The source metadata identifies NDA 050573, NDA 050574, NDA 050625 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QUDEXY XR on 2026-03-09. The source metadata identifies NDA 205122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ERLEADA on 2026-03-09. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Vedic Lifesciences Pvt. Ltd. concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. 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 JZ Wholesale, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text 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 an approval letter for IZERVAY on 2026-03-06. The source metadata identifies NDA 217225 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Espifresh 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 Half Hill Farm Inc. 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 prilla.com/us 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's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name. 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 BAL on 2026-03-05. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Life Plus Style Gourmet LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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 SSS AUSTAR LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Novo Nordisk Inc. concerning Postmarketing Adverse Drug Experience Reporting Requirements. Deterministic full-text screening identifies discussion of Quality systems and CAPA, 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 BOSULIF on 2026-03-04. The source metadata identifies NDA 203341 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRAFTOVI on 2026-03-04. The source metadata identifies NDA 210496 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BOSULIF on 2026-03-04. The source metadata identifies NDA 217729 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRAFTOVI on 2026-03-04. The source metadata identifies NDA 210496 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRACLEER on 2026-03-04. The source metadata identifies NDA 021290, NDA 209279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOLLISTIM AQ on 2026-03-04. The source metadata identifies BLA 021211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROBINUL on 2026-03-04. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Citra100mg 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 issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 202668, ANDA 202669 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 203608, ANDA 203609 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 217295, ANDA 217676 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040278, ANDA 040279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOGROYA on 2026-03-03. The source metadata identifies BLA 761156 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DILTIAZEM HYDROCHLORIDE on 2026-03-03. The source metadata identifies ANDA 218744 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SIVEXTRO on 2026-03-03. The source metadata identifies NDA 205435, NDA 205436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for YUVIWEL on 2026-03-03. The source metadata identifies NDA 219164 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 215699, ANDA 216494 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PREZCOBIX PED, PREZCOBIX on 2026-03-03. The source metadata identifies NDA 220092 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 209219, ANDA 209271 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040743, ANDA 040798 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REBLOZYL on 2026-03-03. The source metadata identifies BLA 761136 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DULOXETINE HYDROCHLORIDE on 2026-03-03. The source metadata identifies NDA 219131 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEPZELCA on 2026-03-03. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 210123, ANDA 210124 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CALCITRIOL on 2026-03-03. The source metadata identifies ANDA 219796 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SILIQ on 2026-03-03. 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 PREZCOBIX on 2026-03-03. The source metadata identifies NDA 205395 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040333, ANDA 040334 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Fareva Morton Grove concerning CGMP/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 Ocean Group Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Quality systems and CAPA, 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 Simtra BioPharma Solutions 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 Barcelona Nut Company Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/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 Tentamus India Private Limited concerning CGMP/Finished Pharmaceuticals/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 issued an approval letter for VYVGART HYTRULO on 2026-03-02. The source metadata identifies BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RIZAFILM on 2026-03-02. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for JASCAYD on 2026-03-02. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENSACOVE on 2026-03-02. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HERNEXEOS on 2026-03-02. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for Xeomin on 2026-03-02. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. 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.