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 1777-1788 of 1819 letters

ALApproval Letter
Approval Letter ESPERION THERAPS INC (Jan 16, 2026)
FDA posted an approval letter for NEXLETOL on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211616 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 16, 2026
US FDA• NEXLETOL
ALApproval Letter
Approval Letter ESPERION THERAPS INC (Jan 16, 2026)
FDA posted an approval letter for NEXLIZET on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211617 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 16, 2026
US FDA• NEXLIZET
ALApproval Letter
Approval Letter EMERGENT (Jan 16, 2026)
FDA posted an approval letter for NARCAN on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 16, 2026
US FDA• NARCAN
WLWarning Letter
Warning Letter East CK Trading Inc. (Jan 16, 2026)
FDA issued a warning letter to East CK Trading 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.
IssuedJan 16, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Zip Foods Importers, Inc (Jan 16, 2026)
FDA issued a warning letter to Zip Foods Importers, 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.
IssuedJan 16, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Feng Foods Trading Inc. (Jan 16, 2026)
FDA issued a warning letter to Feng Foods Trading 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.
IssuedJan 16, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Boothwyn Pharmacy, LLC (Jan 16, 2026)
FDA issued a warning letter to Boothwyn Pharmacy, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA, 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.
IssuedJan 16, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products
ALApproval Letter
Approval Letter CELLTRION INC (Jan 15, 2026)
FDA posted an approval letter for AVTOZMA on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 15, 2026
US FDA• AVTOZMA
ALApproval Letter
Approval Letter NOVARTIS (Jan 15, 2026)
FDA posted an approval letter for GLEEVEC on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 15, 2026
US FDA• GLEEVEC
ALApproval Letter
Approval Letter KENVUE BRANDS (Jan 15, 2026)
FDA posted an approval letter for ROGAINE (FOR MEN), ROGAINE (FOR WOMEN), ROGAINE EXTRA STRENGTH (FOR MEN) on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019501, NDA 020834, NDA 021812 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 15, 2026
US FDA• ROGAINE (FOR MEN) / ROGAINE (FOR WOMEN) / ROGAINE EXTRA STRENGTH (FOR MEN)
ALApproval Letter
Approval Letter BIOCON BIOLOGICS INC (Jan 15, 2026)
FDA posted an approval letter for YESAFILI on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761274 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 15, 2026
US FDA• YESAFILI
WLWarning Letter
Warning Letter The Great Smart African Food LLC (Jan 15, 2026)
FDA issued a warning letter to The Great Smart African Food 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.
IssuedJan 15, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

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Approval Letter ESPERION THERAPS INC (Jan 16, 2026)

Approval Letter ESPERION THERAPS INC (Jan 16, 2026)

Approval Letter EMERGENT (Jan 16, 2026)

Warning Letter East CK Trading Inc. (Jan 16, 2026)

Warning Letter Zip Foods Importers, Inc (Jan 16, 2026)

Warning Letter Feng Foods Trading Inc. (Jan 16, 2026)

Warning Letter Boothwyn Pharmacy, LLC (Jan 16, 2026)

Approval Letter CELLTRION INC (Jan 15, 2026)

Approval Letter NOVARTIS (Jan 15, 2026)

Approval Letter KENVUE BRANDS (Jan 15, 2026)

Approval Letter BIOCON BIOLOGICS INC (Jan 15, 2026)

Warning Letter The Great Smart African Food LLC (Jan 15, 2026)