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 421-432 of 1819 letters

ALApproval Letter
Approval Letter NOVARTIS (Sep 23, 2026)
FDA posted an approval letter for SCEMBLIX on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• SCEMBLIX
ALApproval Letter
Approval Letter ALKERMES INC (Sep 23, 2026)
FDA posted an approval letter for LUMRYZ on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214755 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• LUMRYZ
ALApproval Letter
Approval Letter STERIMAX (Sep 23, 2026)
FDA posted an approval letter for CLAFORAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050547 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• CLAFORAN
ALApproval Letter
Approval Letter UNITED THERAP (Sep 23, 2026)
FDA posted an approval letter for TYVASO DPI on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214324 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• TYVASO DPI
WLWarning Letter
Warning Letter Online Generic Medicine/www.onlinegenericmedicine.com (Sep 23, 2026)
FDA issued a warning letter to Online Generic Medicine/www.onlinegenericmedicine.com concerning Unapproved New Drug/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedSep 23, 2026
US FDA• Unapproved New Drug/Misbranded (Internet Pharmacy)
WLWarning Letter
Warning Letter Neogen Corporation (Sep 23, 2026)
FDA issued a warning letter to Neogen Corporation concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedSep 23, 2026
US FDA• CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
WLWarning Letter
Warning Letter Sciarra Aeromed, Inc. (Sep 23, 2026)
FDA issued a warning letter to Sciarra Aeromed, Inc. concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedSep 23, 2026
US FDA• CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
ALApproval Letter
Approval Letter ELI LILLY AND CO (Sep 22, 2026)
FDA posted an approval letter for VERZENIO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• VERZENIO
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Sep 22, 2026)
FDA posted an approval letter for WINREVAIR on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• WINREVAIR
ALApproval Letter
Approval Letter ELI LILLY AND CO (Sep 22, 2026)
FDA posted an approval letter for INLURIYO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218881 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• INLURIYO
ALApproval Letter
Approval Letter IPSEN (Sep 22, 2026)
FDA posted an approval letter for SOHONOS on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215559 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• SOHONOS
ALApproval Letter
Approval Letter INTRABIO (Sep 22, 2026)
FDA posted an approval letter for AQNEURSA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• AQNEURSA

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Approval Letter NOVARTIS (Sep 23, 2026)

Approval Letter ALKERMES INC (Sep 23, 2026)

Approval Letter STERIMAX (Sep 23, 2026)

Approval Letter UNITED THERAP (Sep 23, 2026)

Warning Letter Online Generic Medicine/www.onlinegenericmedicine.com (Sep 23, 2026)

Warning Letter Neogen Corporation (Sep 23, 2026)

Warning Letter Sciarra Aeromed, Inc. (Sep 23, 2026)

Approval Letter ELI LILLY AND CO (Sep 22, 2026)

Approval Letter MERCK SHARP DOHME (Sep 22, 2026)

Approval Letter ELI LILLY AND CO (Sep 22, 2026)

Approval Letter IPSEN (Sep 22, 2026)

Approval Letter INTRABIO (Sep 22, 2026)