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 853-864 of 1819 letters

ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jun 26, 2026)
FDA posted an approval letter for KEYTRUDA QLEX on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• KEYTRUDA QLEX
ALApproval Letter
Approval Letter IMMUNOMEDICS INC (Jun 26, 2026)
FDA posted an approval letter for TRODELVY on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• TRODELVY
ALApproval Letter
Approval Letter IONIS PHARMS INC (Jun 26, 2026)
FDA posted an approval letter for TRYNGOLZA (AUTOINJECTOR) on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218614 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• TRYNGOLZA (AUTOINJECTOR)
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jun 26, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Jun 26, 2026)
FDA posted an approval letter for ELIQUIS, ELIQUIS SPRINKLE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202155, NDA 220073 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• ELIQUIS / ELIQUIS SPRINKLE
ALApproval Letter
Approval Letter AVYXA HOLDINGS (Jun 26, 2026)
FDA posted an approval letter for NAVITRUX on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220436 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• NAVITRUX
WLWarning Letter
Warning Letter Shouly Import Corp. (Jun 26, 2026)
FDA issued a warning letter to Shouly Import Corp. 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.
IssuedJun 26, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Excelvision - Fareva (Jun 25, 2026)
FDA issued a warning letter to Excelvision - Fareva 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.
IssuedJun 25, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter AMGEN (Jun 24, 2026)
FDA posted an approval letter for PROLIA, XGEVA on 2026-06-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 24, 2026
US FDA• PROLIA / XGEVA
ALApproval Letter
Approval Letter AMGEN (Jun 24, 2026)
FDA posted an approval letter for PROLIA, XGEVA on 2026-06-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 24, 2026
US FDA• PROLIA / XGEVA
WLWarning Letter
Warning Letter Wizcure Pharmaa Private Limited (Jun 24, 2026)
FDA issued a warning letter to Wizcure Pharmaa Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, 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.
IssuedJun 24, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Win Woo Trading, LLC / HF Foods Group (Jun 24, 2026)
FDA issued a warning letter to Win Woo Trading, LLC / HF Foods Group 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.
IssuedJun 24, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

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Approval Letter MERCK SHARP DOHME (Jun 26, 2026)

Approval Letter IMMUNOMEDICS INC (Jun 26, 2026)

Approval Letter IONIS PHARMS INC (Jun 26, 2026)

Approval Letter MERCK SHARP DOHME (Jun 26, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Jun 26, 2026)

Approval Letter AVYXA HOLDINGS (Jun 26, 2026)

Warning Letter Shouly Import Corp. (Jun 26, 2026)

Warning Letter Excelvision - Fareva (Jun 25, 2026)

Approval Letter AMGEN (Jun 24, 2026)

Approval Letter AMGEN (Jun 24, 2026)

Warning Letter Wizcure Pharmaa Private Limited (Jun 24, 2026)

Warning Letter Win Woo Trading, LLC / HF Foods Group (Jun 24, 2026)