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 1297-1308 of 1819 letters

ALApproval Letter
Approval Letter GE HLTHCARE INC (Apr 16, 2026)
FDA posted an approval letter for DATSCAN on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022454 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 16, 2026
US FDA• DATSCAN
ALApproval Letter
Approval Letter ASTRAZENECA AB (Apr 16, 2026)
FDA posted an approval letter for WAINUA (AUTOINJECTOR), WAINUA on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 16, 2026
US FDA• WAINUA (AUTOINJECTOR) / WAINUA
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Apr 16, 2026)
FDA posted an approval letter for STELARA on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 16, 2026
US FDA• STELARA
ALApproval Letter
Approval Letter GENENTECH INC (Apr 16, 2026)
FDA posted an approval letter for ITOVEBI on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219249 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 16, 2026
US FDA• ITOVEBI
ALApproval Letter
Approval Letter AMIVAS (Apr 15, 2026)
FDA posted an approval letter for ARTESUNATE on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213036 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 15, 2026
US FDA• ARTESUNATE
ALApproval Letter
Approval Letter DAIICHI SANKYO INC (Apr 15, 2026)
FDA posted an approval letter for VANFLYTA on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 15, 2026
US FDA• VANFLYTA
ALApproval Letter
Approval Letter DENALI THERAPEUTICS INC. (Apr 15, 2026)
FDA posted an approval letter for AVLAYAH on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761485 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 15, 2026
US FDA• AVLAYAH
ALApproval Letter
Approval Letter GERON (Apr 15, 2026)
FDA posted an approval letter for RYTELO on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217779 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 15, 2026
US FDA• RYTELO
ALApproval Letter
Approval Letter TRAVERE (Apr 15, 2026)
FDA posted an approval letter for FILSPARI on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216403 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 15, 2026
US FDA• FILSPARI
WLWarning Letter
Warning Letter Par Health USA, LLC & Endo USA, Inc. (Apr 15, 2026)
FDA issued a warning letter to Par Health USA, LLC & Endo USA, Inc. 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.
IssuedApr 15, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Hangzhou Yiqi Biotechnology Co., Ltd (Apr 15, 2026)
FDA issued a warning letter to Hangzhou Yiqi Biotechnology Co., Ltd concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, 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.
IssuedApr 15, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
WLWarning Letter
Warning Letter Unetixs Vascular, Inc. (Apr 15, 2026)
FDA issued a warning letter to Unetixs Vascular, Inc. concerning Premarket Approval/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, 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.
IssuedApr 15, 2026
US FDA• Premarket Approval/Adulterated

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Approval Letter GE HLTHCARE INC (Apr 16, 2026)

Approval Letter ASTRAZENECA AB (Apr 16, 2026)

Approval Letter JANSSEN BIOTECH (Apr 16, 2026)

Approval Letter GENENTECH INC (Apr 16, 2026)

Approval Letter AMIVAS (Apr 15, 2026)

Approval Letter DAIICHI SANKYO INC (Apr 15, 2026)

Approval Letter DENALI THERAPEUTICS INC. (Apr 15, 2026)

Approval Letter GERON (Apr 15, 2026)

Approval Letter TRAVERE (Apr 15, 2026)

Warning Letter Par Health USA, LLC & Endo USA, Inc. (Apr 15, 2026)

Warning Letter Hangzhou Yiqi Biotechnology Co., Ltd (Apr 15, 2026)

Warning Letter Unetixs Vascular, Inc. (Apr 15, 2026)