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 1189-1200 of 1819 letters

ALApproval Letter
Approval Letter ACCORD BIOPHARMA INC. (May 12, 2026)
FDA posted an approval letter for ENNUMO on 2026-05-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761147 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 12, 2026
US FDA• ENNUMO
WLWarning Letter
Warning Letter Dough-To-Go, Inc. (May 12, 2026)
FDA issued a warning letter to Dough-To-Go, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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.
IssuedMay 12, 2026
US FDA• CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
WLWarning Letter
Warning Letter Flax & More Corporation (May 12, 2026)
FDA issued a warning letter to Flax & More Corporation concerning CGMP/Dietary Supplement/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedMay 12, 2026
US FDA• CGMP/Dietary Supplement/Adulterated
WLWarning Letter
Warning Letter Fagron BV (May 12, 2026)
FDA issued a warning letter to Fagron BV concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, 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.
IssuedMay 12, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products
ALApproval Letter
Approval Letter ARGENX BV (May 11, 2026)
FDA posted an approval letter for VYVGART, VYVGART HYTRULO on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761195, BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• VYVGART / VYVGART HYTRULO
ALApproval Letter
Approval Letter BRILLIAN PHARMA (May 11, 2026)
FDA posted an approval letter for SDAMLO on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• SDAMLO
ALApproval Letter
Approval Letter BAYER HLTHCARE (May 11, 2026)
FDA posted an approval letter for ADEMPAS on 2026-05-11. 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 FDAMay 11, 2026
US FDA• ADEMPAS
ALApproval Letter
Approval Letter CEDIPROF INC (May 11, 2026)
FDA posted an approval letter for LEVO-T on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• LEVO-T
ALApproval Letter
Approval Letter PFIZER (May 11, 2026)
FDA posted an approval letter for NURTEC ODT on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212728 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• NURTEC ODT
ALApproval Letter
Approval Letter ASTRAZENECA (May 11, 2026)
FDA posted an approval letter for BRILINTA on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022433 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• BRILINTA
ALApproval Letter
Approval Letter GENENTECH INC (May 11, 2026)
FDA posted an approval letter for OCREVUS on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761053 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• OCREVUS
ALApproval Letter
Approval Letter CHEPLAPHARM (May 11, 2026)
FDA posted an approval letter for ZYPREXA RELPREVV on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 11, 2026
US FDA• ZYPREXA RELPREVV

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Approval Letter ACCORD BIOPHARMA INC. (May 12, 2026)

Warning Letter Dough-To-Go, Inc. (May 12, 2026)

Warning Letter Flax & More Corporation (May 12, 2026)

Warning Letter Fagron BV (May 12, 2026)

Approval Letter ARGENX BV (May 11, 2026)

Approval Letter BRILLIAN PHARMA (May 11, 2026)

Approval Letter BAYER HLTHCARE (May 11, 2026)

Approval Letter CEDIPROF INC (May 11, 2026)

Approval Letter PFIZER (May 11, 2026)

Approval Letter ASTRAZENECA (May 11, 2026)

Approval Letter GENENTECH INC (May 11, 2026)

Approval Letter CHEPLAPHARM (May 11, 2026)