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 1453-1464 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter NATCO PHARMA LTD (Mar 20, 2026)
FDA posted a tentative approval letter for ERDAFITINIB on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218578 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• ERDAFITINIB
ALApproval Letter
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)
FDA posted an approval letter for XTORO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• XTORO
ALApproval Letter
Approval Letter ORGANON (Mar 20, 2026)
FDA posted an approval letter for PROSCAR on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• PROSCAR
WLWarning Letter
Warning Letter Nupack Inc. (Mar 20, 2026)
FDA issued a warning letter to Nupack Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedMar 20, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded
WLWarning Letter
Warning Letter matesbrand.com (Mar 20, 2026)
FDA issued a warning letter to matesbrand.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, 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.
IssuedMar 20, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter RC Outsourcing, LLC (Mar 20, 2026)
FDA issued a warning letter to RC Outsourcing, LLC concerning Compounding Pharmacy/Adulterated Drug Products. 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.
IssuedMar 20, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 19, 2026)
FDA posted an approval letter for ORKAMBI on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206038, NDA 211358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• ORKAMBI
ALApproval Letter
Approval Letter INTERCEPT (Mar 19, 2026)
FDA posted an approval letter for LYNAVOY on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220295 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• LYNAVOY
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 19, 2026)
FDA posted an approval letter for ALYFTREK on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• ALYFTREK
ALApproval Letter
Approval Letter PFIZER (Mar 19, 2026)
FDA posted an approval letter for NURTEC ODT on 2026-03-19. 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 FDAMar 19, 2026
US FDA• NURTEC ODT
ALApproval Letter
Approval Letter NOVIMMUNE S.A. (Mar 19, 2026)
FDA posted an approval letter for GAMIFANT on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761107 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• GAMIFANT
ALApproval Letter
Approval Letter VERTEX PHARMS (Mar 19, 2026)
FDA posted an approval letter for KALYDECO on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203188, NDA 207925 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• KALYDECO

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Tentative Approval Letter NATCO PHARMA LTD (Mar 20, 2026)

Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)

Approval Letter ORGANON (Mar 20, 2026)

Warning Letter Nupack Inc. (Mar 20, 2026)

Warning Letter matesbrand.com (Mar 20, 2026)

Warning Letter RC Outsourcing, LLC (Mar 20, 2026)

Approval Letter VERTEX PHARMS INC (Mar 19, 2026)

Approval Letter INTERCEPT (Mar 19, 2026)

Approval Letter VERTEX PHARMS INC (Mar 19, 2026)

Approval Letter PFIZER (Mar 19, 2026)

Approval Letter NOVIMMUNE S.A. (Mar 19, 2026)

Approval Letter VERTEX PHARMS (Mar 19, 2026)