FDA Letters Issued in June 2026

FDA issued an approval letter for ROMVIMZA on 2026-06-30. The source metadata identifies NDA 219304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRELSTAR on 2026-06-30. The source metadata identifies NDA 020715, NDA 021288, NDA 022437 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEVTERA on 2026-06-30. The source metadata identifies NDA 218275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SKYRIZI on 2026-06-30. 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 SARCLISA on 2026-06-30. The source metadata identifies BLA 761113 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN 0.9% SODIUM CHLORIDE on 2026-06-30. The source metadata identifies NDA 206769 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'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 CEFEPIME IN PLASTIC CONTAINER on 2026-06-29. The source metadata identifies NDA 050817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BICILLIN L-A, BICILLIN C-R, BICILLIN C-R 900/300 on 2026-06-29. The source metadata identifies NDA 050141, NDA 050138 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for Xeomin on 2026-06-29. 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 ARIKAYCE KIT on 2026-06-29. The source metadata identifies NDA 207356 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BICILLIN C-R, BICILLIN C-R 900/300, BICILLIN L-A on 2026-06-29. The source metadata identifies NDA 050138, NDA 050141 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 2026-06-29. 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 BESREMI on 2026-06-29. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

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

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 ORSERDU on 2026-06-26. The source metadata identifies NDA 217639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IBRANCE on 2026-06-26. The source metadata identifies NDA 212436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IBRANCE on 2026-06-26. The source metadata identifies NDA 207103 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-26. 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 TRODELVY on 2026-06-26. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SPRAVATO on 2026-06-26. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-06-26. 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 TRODELVY on 2026-06-26. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRYNGOLZA (AUTOINJECTOR) on 2026-06-26. The source metadata identifies NDA 218614 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-26. 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 ELIQUIS, ELIQUIS SPRINKLE on 2026-06-26. The source metadata identifies NDA 202155, NDA 220073 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NAVITRUX on 2026-06-26. The source metadata identifies NDA 220436 as an original application. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued an approval letter for PROLIA, XGEVA on 2026-06-24. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROLIA, XGEVA on 2026-06-24. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Wizcure Pharmaa Private Limited 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 Win Woo Trading, LLC / HF Foods Group concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 XTAMPZA ER on 2026-06-23. The source metadata identifies NDA 208090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR) on 2026-06-23. The source metadata identifies NDA 214231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MS CONTIN on 2026-06-23. The source metadata identifies NDA 019516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA on 2026-06-23. The source metadata identifies NDA 203794 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DILAUDID on 2026-06-23. The source metadata identifies NDA 019891, NDA 019892 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 on 2026-06-23. The source metadata identifies NDA 018891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FIORICET W/ CODEINE on 2026-06-23. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CYSVIEW KIT on 2026-06-23. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SYNALGOS-DC on 2026-06-23. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MORPHINE SULFATE on 2026-06-23. The source metadata identifies NDA 022207 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXAYDO on 2026-06-23. The source metadata identifies NDA 202080 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CONZIP on 2026-06-23. The source metadata identifies NDA 022370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QDOLO on 2026-06-23. The source metadata identifies NDA 214044 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PYRUKYND, AQVESME on 2026-06-23. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200534 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PERCODAN-DEMI, PERCODAN on 2026-06-23. The source metadata identifies NDA 007337 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MORPHINE SULFATE on 2026-06-23. The source metadata identifies NDA 022195 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BELBUCA on 2026-06-23. The source metadata identifies NDA 207932 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA on 2026-06-23. The source metadata identifies NDA 022304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 022402 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEMEROL on 2026-06-23. The source metadata identifies NDA 005010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROXICODONE on 2026-06-23. The source metadata identifies NDA 021011 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 201194 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BUTRANS on 2026-06-23. The source metadata identifies NDA 021306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROXYBOND on 2026-06-23. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA ER on 2026-06-23. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HYSINGLA ER on 2026-06-23. The source metadata identifies NDA 206627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCONTIN on 2026-06-23. The source metadata identifies NDA 022272 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 202245 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TWIRLA on 2026-06-23. The source metadata identifies NDA 204017 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to LyfeUnit / www.lyfeunit.com 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 Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com 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 Med Shop Inc / www.medshopinc.com 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 Allandale Dairy concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Keta Med Lab / www.ketamedlab.com 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 Legit Ketamine Suppliers / www.legitketaminesuppliers.com 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 Extra Medication / www.extramedication.com 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 Ketacyn Pharmaceuticals / www.ketacynpharma.com 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 ketaminetroches.com 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 Ketdaxandrugs / www.ketdaxandrugs.org 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 Ket Plug / ketaminelab.org and buyketaminepowderonline.com 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 Buy Keta Online / www.buyketaonline.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to All Ketamine HCL / www.allketaminehcl.com 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 Ketamine Store / www.ketaminestore.org concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Genzyme Ireland Limited concerning CGMP/Deviations/Biologics License Application (BLA). 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'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 UTEBZI on 2026-06-18. The source metadata identifies NDA 215960 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPKINLY on 2026-06-18. 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 PARICALCITOL on 2026-06-18. The source metadata identifies NDA 205917 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BALOXAVIR MARBOXIL on 2026-06-18. The source metadata identifies ANDA 217449 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OCREVUS ZUNOVO on 2026-06-18. The source metadata identifies BLA 761371 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for APREPITANT on 2026-06-17. The source metadata identifies NDA 218754 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN on 2026-06-17. The source metadata identifies NDA 020883 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMODIUM MULTI-SYMPTOM RELIEF on 2026-06-17. The source metadata identifies NDA 021140 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Texinkart 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 Herbal Dermals LLC FZ dba Gotucream 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 Hadassah Healing Oils Ltd concerning Unapproved New Drugs. 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 Telos Trading Limited dba Alwinshop 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 Leading Edge Health Inc. 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 Amazon.com, Inc. 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 Wild Arabic Herbs 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 Indiangoods.shop 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 Great India Overseas Pvt. Ltd. dba Silkrute concerning Unapproved New Drugs. 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 Wholesale Peptide 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 MantroForce 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 JJLBRO 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 an approval letter for AMBELVIST on 2026-06-16. The source metadata identifies NDA 219627 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ABSORICA LD on 2026-06-16. The source metadata identifies NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-06-16. 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 YERVOY on 2026-06-16. The source metadata identifies BLA 125377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRUQAP on 2026-06-16. 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 CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, SKYRIZI on 2026-06-16. The source metadata identifies ANDA 076126, BLA 761105 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REXTOVY on 2026-06-16. The source metadata identifies NDA 208969 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WIDAPLIK on 2026-06-16. The source metadata identifies NDA 219423 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WELIREG on 2026-06-16. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Bioequivalence and pharmacokinetics. 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 ALECENSA on 2026-06-15. The source metadata identifies NDA 208434 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, DEXTROSE 10% IN PLASTIC CONTAINER on 2026-06-15. The source metadata identifies NDA 016673, NDA 016694 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BAXFENDY on 2026-06-15. The source metadata identifies NDA 219878 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TZIELD on 2026-06-15. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Life & Food 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 Happiest Baby, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic source-metadata screening identifies discussion of 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 Huons Co., Ltd. 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 Yangzhou Hongshengding Chemical Co., Ltd. concerning Refusal to Provide Access to and Copying of Records. 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 AHC Products, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nihon Kohden Digital Health Solutions, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). 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 an approval letter for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-06-11. The source metadata identifies NDA 206473 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EXDENSUR on 2026-06-11. The source metadata identifies BLA 761458 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 2026-06-11. The source metadata identifies NDA 022434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER on 2026-06-11. The source metadata identifies NDA 050671 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VORANIGO on 2026-06-11. The source metadata identifies NDA 218784 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUORESCITE on 2026-06-11. The source metadata identifies NDA 021980 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DARZALEX on 2026-06-11. The source metadata identifies BLA 761036 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TERLIVAZ on 2026-06-11. The source metadata identifies NDA 022231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOTYKTU on 2026-06-11. 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 ZYVOX on 2026-06-11. The source metadata identifies NDA 021130, NDA 021131, NDA 021132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EBGLYSS on 2026-06-11. The source metadata identifies BLA 761306 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 2026-06-11. The source metadata identifies NDA 209552 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-06-11. 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 CEPHALEXIN on 2026-06-11. The source metadata identifies ANDA 213568 as an original application. 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 an approval letter for RIFAXIMIN on 2026-06-09. The source metadata identifies ANDA 208959 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211583 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MESALAMINE on 2026-06-09. The source metadata identifies ANDA 219997 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROVOCHOLINE on 2026-06-09. The source metadata identifies NDA 019193 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) on 2026-06-09. The source metadata identifies ANDA 210456 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC on 2026-06-09. The source metadata identifies ANDA 210671 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CANAGLIFLOZIN on 2026-06-09. 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 MULTIPLE VITAMINS INJECTION ADULT on 2026-06-09. The source metadata identifies ANDA 210273 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPDUALAG on 2026-06-09. The source metadata identifies BLA 761234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HYMPAVZI on 2026-06-09. The source metadata identifies BLA 761369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPIDIOLEX on 2026-06-09. The source metadata identifies NDA 210365 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EMGALITY on 2026-06-09. The source metadata identifies BLA 761063 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 218760 on 2026-06-09. The source metadata identifies ANDA 218760 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211563 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NINTEDANIB ESYLATE on 2026-06-09. The source metadata identifies ANDA 212609 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for APREPITANT on 2026-06-09. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALBUTEROL SULFATE on 2026-06-09. The source metadata identifies ANDA 219409 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENZALUTAMIDE on 2026-06-09. The source metadata identifies ANDA 216068 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CITALOPRAM HYDROBROMIDE on 2026-06-09. The source metadata identifies ANDA 219985 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 212211 on 2026-06-09. The source metadata identifies ANDA 212211 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMULDOSA on 2026-06-09. The source metadata identifies BLA 761364 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VYEPTI on 2026-06-09. The source metadata identifies BLA 761119 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FERRIC CITRATE on 2026-06-09. The source metadata identifies ANDA 212563 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN on 2026-06-09. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220169 on 2026-06-08. The source metadata identifies ANDA 220169 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220025 on 2026-06-08. The source metadata identifies ANDA 220025 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TOFACITINIB CITRATE on 2026-06-08. The source metadata identifies ANDA 215356 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE on 2026-06-08. The source metadata identifies ANDA 220483 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES on 2026-06-08. The source metadata identifies NDA 021909 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220352 on 2026-06-08. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Maximus Health, Inc. dba Maximus concerning False & Misleading Claims/Misbranded (Telehealth). 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 Medica Weight Loss concerning False & Misleading Claims/Misbranded (Telehealth). 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 HydraMed IV LLC dba HydraMed concerning False & Misleading Claims/Misbranded (Telehealth). 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 FITISH concerning False & Misleading Claims/Misbranded (Telehealth). 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 Momentum Health 360 dba Momentum Health concerning False & Misleading Claims/Misbranded (Telehealth). 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 Ezra Holdco LLC dba Ezra concerning False & Misleading Claims/Misbranded (Telehealth). 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 Nova Vascular LLC dba NOVARX concerning False & Misleading Claims/Misbranded (Telehealth). 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 NativeMed LLC dba NativeMed concerning False & Misleading Claims/Misbranded (Telehealth). 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 Delight Distribution 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 OrderlyMeds LLC dba OrderlyMeds concerning False & Misleading Claims/Misbranded (Telehealth). 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 Eden Health International Inc. dba Eden concerning False & Misleading Claims/Misbranded (Telehealth). 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 D&H Medical Services concerning False & Misleading Claims/Misbranded (Telehealth). 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 Roen Health, Inc. dba RoenRx concerning False & Misleading Claims/Misbranded (Telehealth). 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 Trinity HealthCare Supply, LLC dba altRx concerning False & Misleading Claims/Misbranded (Telehealth). 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 Vivot 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 Altru Telehealth, LLC dba Altru Telehealth concerning False & Misleading Claims/Misbranded (Telehealth). 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 Nexlife Inc. dba Nexlife concerning False & Misleading Claims/Misbranded (Telehealth). 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 Public Health Solution LLC dba DrMedHealth concerning False & Misleading Claims/Misbranded (Telehealth). 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 VivioMD Group LLC dba VivioMD concerning False & Misleading Claims/Misbranded (Telehealth). 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 Ready Med concerning False & Misleading Claims/Misbranded (Telehealth). 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 Joi and Blokes dba Joi + Blokes concerning False & Misleading Claims/Misbranded (Telehealth). 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 Amie Health, Inc. dba Amie concerning False & Misleading Claims/Misbranded (Telehealth). 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 Nexus Health Solutions LLC dba Harper Meds concerning False & Misleading Claims/Misbranded (Telehealth). 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 Clover Meds LLC dba Clover Meds concerning False & Misleading Claims/Misbranded (Telehealth). 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 FitRX, LLC dba AM RX concerning False & Misleading Claims/Misbranded (Telehealth). 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 YS Group 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 Thrivelab Co. dba Thrivelab concerning False & Misleading Claims/Misbranded (Telehealth). 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 Glow Medispa, LLC dba Mint Med concerning False & Misleading Claims/Misbranded (Telehealth). 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 tentative approval letter for CENOBAMATE on 2026-06-05. The source metadata identifies ANDA 219473 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STEGLUJAN on 2026-06-05. The source metadata identifies NDA 209805 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CYCLOPHOSPHAMIDE on 2026-06-05. The source metadata identifies ANDA 219271 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FASENRA on 2026-06-05. The source metadata identifies BLA 761070 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STEGLATRO on 2026-06-05. The source metadata identifies NDA 209803 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FARXIGA on 2026-06-05. The source metadata identifies NDA 202293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QTERN on 2026-06-05. The source metadata identifies NDA 209091 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN DEXTROSE on 2026-06-05. The source metadata identifies NDA 201743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INVOKANA on 2026-06-05. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRENZAVVY on 2026-06-05. The source metadata identifies NDA 214373 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Imu-Tek Animal Health, Incorporated concerning Dietary Supplement/New Drug/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 Mineral BioSciences, LLC concerning Unapproved New Drugs/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 Sante Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. 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 AseptiKits, LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. 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 Nutratech, LLC concerning CGMP/Dietary Supplement/Adulterated/Misbranded. 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 an approval letter for FUROSEMIDE on 2026-06-03. The source metadata identifies NDA 018569 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SAXENDA on 2026-06-03. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RANLUSPEC on 2026-06-03. The source metadata identifies BLA 761480 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to BlephEx, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, 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 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/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 InvaDerm, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/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 an approval letter for ARFORMOTEROL TARTRATE on 2026-06-02. The source metadata identifies ANDA 218429 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZAYNICH on 2026-06-02. The source metadata identifies NDA 220787 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRIVARACETAM on 2026-06-02. The source metadata identifies ANDA 214924 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CAVHANZA on 2026-06-02. The source metadata identifies NDA 217379 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XOCOVA on 2026-06-02. The source metadata identifies NDA 220442 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OZEMPIC on 2026-06-02. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WELLCOVORIN on 2026-06-02. The source metadata identifies NDA 018342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IDELALISIB on 2026-06-02. The source metadata identifies ANDA 216921 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AJOVY on 2026-06-02. The source metadata identifies BLA 761089 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-02. 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 SOLIRIS, ULTOMIRIS on 2026-06-02. The source metadata identifies BLA 125166, BLA 761108 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 217060 on 2026-06-02. The source metadata identifies ANDA 217060 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for MILNACIPRAN HYDROCHLORIDE on 2026-06-02. The source metadata identifies ANDA 210944 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 217786 on 2026-06-02. The source metadata identifies ANDA 217786 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 212283 on 2026-06-02. The source metadata identifies ANDA 212283 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SITAGLIPTIN PHOSPHATE on 2026-06-02. The source metadata identifies ANDA 215155 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IPRATROPIUM BROMIDE on 2026-06-02. The source metadata identifies ANDA 217953 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AFINITOR, AFINITOR DISPERZ on 2026-06-02. The source metadata identifies NDA 022334, NDA 203985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CIPEPOFOL on 2026-06-02. The source metadata identifies NDA 220482 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BIKTARVY on 2026-06-02. The source metadata identifies NDA 210251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AFREZZA on 2026-06-02. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to M G R Produce 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 PLZ Corp 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 Gopaldas Visram & Co., Ltd. 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 SL Follen Company 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 Zydus Lifesciences Limited concerning Request for Records/CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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 Umendra Life Sciences Private Limited concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text 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 Shantou Qiwei Industry Co., LTD concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text 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 Erkul Kozmetik Sanayi ve Ticaret A.S. concerning CGMP/OTC Finished Pharmaceuticals/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 Revlon Group Holdings, LLC 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 Laboratorios Dr. Collado S.A. 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 Asanuma Corporation - Sagamihara Factory 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.