FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,819 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 613-624 of 1819 letters

ALApproval Letter
Approval Letter HQ SPCLT PHARMA (Aug 11, 2026)
FDA posted an approval letter for MEROPENEM on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215212 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 11, 2026
US FDA• MEROPENEM
ALApproval Letter
Approval Letter PRIMUS PHARMS (Aug 11, 2026)
FDA posted an approval letter for SERNIVO on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208079 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 11, 2026
US FDA• SERNIVO
ALApproval Letter
Approval Letter IDORSIA (Aug 10, 2026)
FDA posted an approval letter for TRYVIO on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217686 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 10, 2026
US FDA• TRYVIO
ALApproval Letter
Approval Letter LEXICON PHARMS INC (Aug 10, 2026)
FDA posted an approval letter for INPEFA on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216203 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 10, 2026
US FDA• INPEFA
ALApproval Letter
Approval Letter GENENTECH (Aug 10, 2026)
FDA posted an approval letter for XOLAIR on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103976 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 10, 2026
US FDA• XOLAIR
WLWarning Letter
Warning Letter Safrel Pharmaceuticals LLC (Aug 7, 2026)
FDA issued a warning letter to Safrel Pharmaceuticals LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 7, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Pine Pharmaceuticals, LLC (Aug 7, 2026)
FDA issued a warning letter to Pine Pharmaceuticals, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 7, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products
WLWarning Letter
Warning Letter giantnic.com (Aug 7, 2026)
FDA issued a warning letter to giantnic.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 7, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter mikuvape.com (Aug 7, 2026)
FDA issued a warning letter to mikuvape.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 7, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter BAYER HLTHCARE (Aug 6, 2026)
FDA posted an approval letter for ADEMPAS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• ADEMPAS
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Aug 6, 2026)
FDA posted an approval letter for ORZEYFUL on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220860 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• ORZEYFUL
ALApproval Letter
Approval Letter RADIUS (Aug 6, 2026)
FDA posted an approval letter for TYMLOS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• TYMLOS

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Approval Letter HQ SPCLT PHARMA (Aug 11, 2026)

Approval Letter PRIMUS PHARMS (Aug 11, 2026)

Approval Letter IDORSIA (Aug 10, 2026)

Approval Letter LEXICON PHARMS INC (Aug 10, 2026)

Approval Letter GENENTECH (Aug 10, 2026)

Warning Letter Safrel Pharmaceuticals LLC (Aug 7, 2026)

Warning Letter Pine Pharmaceuticals, LLC (Aug 7, 2026)

Warning Letter giantnic.com (Aug 7, 2026)

Warning Letter mikuvape.com (Aug 7, 2026)

Approval Letter BAYER HLTHCARE (Aug 6, 2026)

Approval Letter TAKEDA PHARMS USA (Aug 6, 2026)

Approval Letter RADIUS (Aug 6, 2026)