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 1,503 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 973-984 of 1503 letters

ALApproval Letter
Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026)
FDA issued an approval letter for COSENTYX on 2026-04-20. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 20, 2026
US FDA• COSENTYX
ALApproval Letter
Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026)
FDA issued an approval letter for COSENTYX on 2026-04-20. The source metadata identifies BLA 761349, BLA 125504 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 20, 2026
US FDA• COSENTYX
ALApproval Letter
Approval Letter SANDOZ INC (Apr 20, 2026)
FDA issued an approval letter for ZARXIO on 2026-04-20. The source metadata identifies BLA 125553 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 20, 2026
US FDA• ZARXIO
ALApproval Letter
Approval Letter REGENERON PHARMACEUTICALS (Apr 20, 2026)
FDA issued an approval letter for DUPIXENT on 2026-04-20. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 20, 2026
US FDA• DUPIXENT
WLWarning Letter
Warning Letter Foshan Miwei Cosmetics Co., Ltd. (Apr 20, 2026)
FDA issued a warning letter to Foshan Miwei Cosmetics Co., Ltd. concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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 20, 2026
US FDA• Nonprescription/OTC
WLWarning Letter
Warning Letter Respilon Production S.R.O. (Apr 20, 2026)
FDA issued a warning letter to Respilon Production S.R.O. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of 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.
IssuedApr 20, 2026
US FDA• CGMP/OTC/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter SaNOtize (Apr 17, 2026)
FDA issued a warning letter to SaNOtize concerning Unapproved New Drugs. 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.
IssuedApr 17, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter nicoprof.com (Apr 17, 2026)
FDA issued a warning letter to nicoprof.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.
IssuedApr 17, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Great Enterprise - Group - Inc. (Apr 17, 2026)
FDA issued a warning letter to Great Enterprise - Group - Inc. 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.
IssuedApr 17, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter BIOCODEX SA (Apr 16, 2026)
FDA issued an approval letter for DIACOMIT on 2026-04-16. The source metadata identifies NDA 206709, NDA 207223 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 16, 2026
US FDA• DIACOMIT
ALApproval Letter
Approval Letter GE HLTHCARE INC (Apr 16, 2026)
FDA issued an approval letter for DATSCAN on 2026-04-16. The source metadata identifies NDA 022454 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 16, 2026
US FDA• DATSCAN
ALApproval Letter
Approval Letter ASTRAZENECA AB (Apr 16, 2026)
FDA issued an approval letter for WAINUA (AUTOINJECTOR), WAINUA on 2026-04-16. The source metadata identifies NDA 217388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 16, 2026
US FDA• WAINUA (AUTOINJECTOR) / WAINUA

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Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026)

Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026)

Approval Letter SANDOZ INC (Apr 20, 2026)

Approval Letter REGENERON PHARMACEUTICALS (Apr 20, 2026)

Warning Letter Foshan Miwei Cosmetics Co., Ltd. (Apr 20, 2026)

Warning Letter Respilon Production S.R.O. (Apr 20, 2026)

Warning Letter SaNOtize (Apr 17, 2026)

Warning Letter nicoprof.com (Apr 17, 2026)

Warning Letter Great Enterprise - Group - Inc. (Apr 17, 2026)

Approval Letter BIOCODEX SA (Apr 16, 2026)

Approval Letter GE HLTHCARE INC (Apr 16, 2026)

Approval Letter ASTRAZENECA AB (Apr 16, 2026)