FDA Letters Issued in February 2026

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. 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 a complete response letter. No controlled deficiency theme met the deterministic text-matching threshold; review the exact redacted letter.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical 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 ZIOPTAN on 2026-02-27. The source metadata identifies NDA 202514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-02-27. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SAXENDA on 2026-02-27. 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 WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-02-27. 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 ENTYVIO on 2026-02-27. The source metadata identifies BLA 125476, BLA 761133 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DESMODA on 2026-02-27. The source metadata identifies NDA 219873 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NEFFY on 2026-02-27. 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 JUXTAPID on 2026-02-27. The source metadata identifies NDA 203858 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

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

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

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

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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 Longhorn Vaccines and Diagnostics LLC 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 ZYNLONTA on 2026-02-24. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SUSTOL on 2026-02-24. The source metadata identifies NDA 022445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FAVLYXA on 2026-02-24. The source metadata identifies NDA 220201 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELUCIREM on 2026-02-24. The source metadata identifies NDA 216986 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LOARGYS on 2026-02-24. The source metadata identifies BLA 761211 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BYSANTI on 2026-02-24. The source metadata identifies NDA 220358 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DUPIXENT on 2026-02-24. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VABOMERE on 2026-02-24. The source metadata identifies NDA 209776 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued a warning letter to IsoTis OrthoBiologics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for CALQUENCE on 2026-02-23. The source metadata identifies NDA 210259, NDA 216387 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for POTELIGEO on 2026-02-23. The source metadata identifies BLA 761051 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VFEND on 2026-02-23. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELREXFIO on 2026-02-23. 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 VENCLEXTA on 2026-02-23. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EVRYSDI on 2026-02-20. The source metadata identifies NDA 213535, NDA 219285 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROBINUL on 2026-02-20. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RYBREVANT FASPRO on 2026-02-20. The source metadata identifies BLA 761484 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AIR on 2026-02-20. The source metadata identifies NDA 221287 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Genesis Health International Inc. dba Genesis 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 Peaks Curative, LLC dba Peaks 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 Join Josie 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 Kin Meds 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 Premium Health Management Inc. dba Premium Health 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 Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics 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 Levity Inc. dba Levity 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 Ivim Services LLC dba Ivim 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 PharmaZee 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 Weightless Medical LLC dba WeightCare 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 Newman Clinic, PLLC dba Newman Clinic 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 Lean Rx, Inc. dba SkinnyRx 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 Better Health Labs, Inc. dba Measured 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 MEDVi, LLC dba MEDVi 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 Alan Health Technologies Inc. dba Alan 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 Refills Health, LLC dba Refills 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 FitRX, LLC dba FitRx 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 Zeuss LLC dba Zeuss 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 Strut Health, LLC dba Strut 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 Kare Solutions, LLC dba Zappy 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 Viv Health, Inc. dba VIV 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 Good Girl LLC dba GoodGirlRX 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 Bliv Wellness LLC dba Bliv 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 NewSelf Limited dba NewSelf 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 24HrDoc, Inc. dba 24HrDoc 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 Belle Health LLC dba Belle 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 Dripgym Mobile Parent, LLC dba Amp Health 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 BluefitMD 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 MaxLife Technologies Inc. dba Maxlife 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 Aspen Aesthetics dba Fifty 410 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 an approval letter for ARBLI on 2026-02-19. The source metadata identifies NDA 218772 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EBANGA on 2026-02-19. The source metadata identifies BLA 761172 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DIPRIVAN on 2026-02-19. The source metadata identifies NDA 019627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REVATIO on 2026-02-19. The source metadata identifies NDA 022473, NDA 021845 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued a warning letter to JMT Inter 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 an approval letter for CEFAZOLIN SODIUM on 2026-02-18. The source metadata identifies NDA 211413 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EOVIST, GADAVIST on 2026-02-18. The source metadata identifies NDA 022090, NDA 201277 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AVOPEF on 2026-02-18. The source metadata identifies NDA 220200 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WAKIX on 2026-02-18. The source metadata identifies NDA 211150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RAPIBLYK on 2026-02-18. The source metadata identifies NDA 217202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Raw Bistro Inc. concerning CGMP/Food for Animals/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's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for CLEOCIN PHOSPHATE, CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-02-13. The source metadata identifies NDA 050441, NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DARZALEX FASPRO on 2026-02-13. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CLEOCIN HYDROCHLORIDE on 2026-02-13. 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 ADQUEY on 2026-02-13. The source metadata identifies NDA 219474 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PEPCID AC on 2026-02-13. The source metadata identifies NDA 020325 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CAMCEVI KIT on 2026-02-13. The source metadata identifies NDA 211488 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LEQVIO on 2026-02-13. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued an approval letter for BIJUVA on 2026-02-12. The source metadata identifies NDA 210132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-02-12. 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 KEYTRUDA QLEX on 2026-02-12. 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 DIVIGEL on 2026-02-12. The source metadata identifies NDA 022038 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AUBAGIO on 2026-02-12. The source metadata identifies NDA 202992 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CENESTIN on 2026-02-12. The source metadata identifies NDA 020992 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROMETRIUM on 2026-02-12. The source metadata identifies NDA 019781 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENJUVIA on 2026-02-12. The source metadata identifies NDA 021443 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PAXLOVID (COPACKAGED) on 2026-02-12. The source metadata identifies NDA 217188 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NARCAN on 2026-02-12. The source metadata identifies NDA 208411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ESTRING on 2026-02-12. The source metadata identifies NDA 020472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENZEEVU on 2026-02-12. The source metadata identifies BLA 761382 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc. 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 Black Sheep Egg Company, LLC concerning PHS Act/Shell Egg Regulation/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 A. Nelson & 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 tentative approval letter for ANDA 219440 on 2026-02-11. The source metadata identifies ANDA 219440 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MIRABEGRON on 2026-02-11. The source metadata identifies ANDA 219323 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. The source metadata identifies ANDA 214378 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BORTEZOMIB on 2026-02-11. The source metadata identifies ANDA 219167 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for RIFAXIMIN on 2026-02-11. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CONJUGATED ESTROGENS on 2026-02-11. The source metadata identifies ANDA 214025 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CONJUGATED ESTROGENS on 2026-02-11. The source metadata identifies ANDA 214023 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. The source metadata identifies ANDA 219119 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SELENIOUS ACID on 2026-02-11. The source metadata identifies ANDA 220051 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220525 on 2026-02-11. The source metadata identifies ANDA 220525 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for AMPHETAMINE on 2026-02-11. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TICAGRELOR on 2026-02-11. The source metadata identifies ANDA 217679 as an original application. Review the exact FDA letter for the approved conditions and labeling.

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

FDA issued an approval letter for ABSORICA, ABSORICA LD on 2026-02-10. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REGLAN on 2026-02-10. The source metadata identifies NDA 017862 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REGLAN on 2026-02-10. The source metadata identifies NDA 017854 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for GIMOTI on 2026-02-10. The source metadata identifies NDA 209388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to ProDx Health concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). 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 Hearthy Foods, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

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

FDA issued an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-02-09. The source metadata identifies NDA 214313 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Thrive Health and Wellness, LLC dba Thrive Health Solutions concerning Compounding Pharmacy/Adulterated Drug Products. 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's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Labeling, packaging, and proprietary name, Statistical analysis. 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 MYQORZO on 2026-02-06. The source metadata identifies NDA 219083 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE on 2026-02-06. The source metadata identifies NDA 050734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Cosmetic Manufacturers Pty Ltd. 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 ExThera Medical Corporation concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for DYNA-HEX 2 on 2026-02-05. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BINOSTO on 2026-02-05. The source metadata identifies NDA 202344 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOSAMAX on 2026-02-05. The source metadata identifies NDA 020560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOSAMAX PLUS D on 2026-02-05. The source metadata identifies NDA 021762 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VYKOURA on 2026-02-05. The source metadata identifies NDA 220406 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STIVARGA on 2026-02-05. The source metadata identifies NDA 203085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ACTONEL on 2026-02-05. The source metadata identifies NDA 020835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ATELVIA on 2026-02-05. The source metadata identifies NDA 022560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RECLAST on 2026-02-05. The source metadata identifies NDA 021817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DYNA-HEX 4 on 2026-02-05. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ATROPINE SULFATE on 2026-02-05. The source metadata identifies NDA 214652 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation 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 Beach Weekend Management LLC dba Nic and Jet Fuel concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for LIVDELZI on 2026-02-03. The source metadata identifies NDA 217899 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE on 2026-02-03. The source metadata identifies ANDA 214095 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LYBALVI on 2026-02-03. The source metadata identifies NDA 213378 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYPREXA, ZYPREXA ZYDIS, ZYPREXA RELPREVV on 2026-02-03. The source metadata identifies NDA 020592, NDA 021086, NDA 021253, NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RYBELSUS, OZEMPIC on 2026-02-03. The source metadata identifies NDA 213051 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENBREL on 2026-02-03. The source metadata identifies BLA 103795 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE HIVES RELIEF on 2026-02-03. The source metadata identifies NDA 022429 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Mark S. Dacey, 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 Apollo Care, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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 Bertrand P. Cole, D.O. 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.