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 1585-1596 of 1819 letters

ALApproval Letter
Approval Letter VANDA PHARMS INC (Feb 24, 2026)
FDA posted an approval letter for BYSANTI on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220358 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• BYSANTI
ALApproval Letter
Approval Letter REGENERON PHARMACEUTICALS (Feb 24, 2026)
FDA posted an approval letter for DUPIXENT on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• DUPIXENT
ALApproval Letter
Approval Letter REMPEX (Feb 24, 2026)
FDA posted an approval letter for VABOMERE on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209776 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• VABOMERE
WLWarning Letter
Warning Letter Trangs Group USA Incorporated (Feb 24, 2026)
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.
IssuedFeb 24, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter IsoTis OrthoBiologics, Inc. (Feb 24, 2026)
FDA issued a warning letter to IsoTis OrthoBiologics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, 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.
IssuedFeb 24, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter ASTRAZENECA (Feb 23, 2026)
FDA posted an approval letter for CALQUENCE on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210259, NDA 216387 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 23, 2026
US FDA• CALQUENCE
ALApproval Letter
Approval Letter KYOWA KIRIN (Feb 23, 2026)
FDA posted an approval letter for POTELIGEO on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761051 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 23, 2026
US FDA• POTELIGEO
ALApproval Letter
Approval Letter PF PRISM CV (Feb 23, 2026)
FDA posted an approval letter for VFEND on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 23, 2026
US FDA• VFEND
ALApproval Letter
Approval Letter PFIZER INC (Feb 23, 2026)
FDA posted an approval letter for ELREXFIO on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 23, 2026
US FDA• ELREXFIO
ALApproval Letter
Approval Letter ABBVIE (Feb 23, 2026)
FDA posted an approval letter for VENCLEXTA on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 23, 2026
US FDA• VENCLEXTA
ALApproval Letter
Approval Letter GENENTECH INC (Feb 20, 2026)
FDA posted an approval letter for EVRYSDI on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213535, NDA 219285 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 20, 2026
US FDA• EVRYSDI
ALApproval Letter
Approval Letter HIKMA (Feb 20, 2026)
FDA posted an approval letter for ROBINUL on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 20, 2026
US FDA• ROBINUL

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Approval Letter VANDA PHARMS INC (Feb 24, 2026)

Approval Letter REGENERON PHARMACEUTICALS (Feb 24, 2026)

Approval Letter REMPEX (Feb 24, 2026)

Warning Letter Trangs Group USA Incorporated (Feb 24, 2026)

Warning Letter IsoTis OrthoBiologics, Inc. (Feb 24, 2026)

Approval Letter ASTRAZENECA (Feb 23, 2026)

Approval Letter KYOWA KIRIN (Feb 23, 2026)

Approval Letter PF PRISM CV (Feb 23, 2026)

Approval Letter PFIZER INC (Feb 23, 2026)

Approval Letter ABBVIE (Feb 23, 2026)

Approval Letter GENENTECH INC (Feb 20, 2026)

Approval Letter HIKMA (Feb 20, 2026)