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 37-48 of 1503 letters

CRLComplete Response Letter
Complete Response Letter GlaxoSmithKline LLC (Dec 16, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 16, 2025
US FDA• EXDENSUR
CRLComplete Response Letter
Complete Response Letter LIB Therapeutics, Inc. (Dec 12, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 12, 2025
US FDA• LEROCHOL
CRLComplete Response Letter
Complete Response Letter Sandoz Inc. (Dec 9, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 9, 2025
US FDA• BLA 761271
CRLComplete Response Letter
Complete Response Letter Alvotech USA Inc. (Nov 26, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 26, 2025
US FDA• BLA 761461
CRLComplete Response Letter
Complete Response Letter Alvotech USA Inc. (Nov 24, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 24, 2025
US FDA• BLA 761435
CRLComplete Response Letter
Complete Response Letter Accord Healthcare Inc. (Nov 6, 2025)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 6, 2025
US FDA• NDA 216987
CRLComplete Response Letter
Complete Response Letter Biohaven Therapeutics, Ltd. (Nov 4, 2025)
FDA's complete response letter contains source-text evidence related to Statistical analysis, Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 4, 2025
US FDA• NDA 210862
CRLComplete Response Letter
Complete Response Letter Alvotech USA Inc. (Oct 31, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 31, 2025
US FDA• BLA 761462
CRLComplete Response Letter
Complete Response Letter Shanghai Auzone Biological Technology Co., Ltd. (Oct 23, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 23, 2025
US FDA• NDA 219846
CRLComplete Response Letter
Complete Response Letter GlaxoSmithKline LLC (Oct 23, 2025)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 23, 2025
US FDA• BLENREP
CRLComplete Response Letter
Complete Response Letter SYDNEXIS Inc. (Oct 22, 2025)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 22, 2025
US FDA• NDA 219694
CRLComplete Response Letter
Complete Response Letter NeuroDerm, Ltd. (Oct 21, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 21, 2025
US FDA• NDA 218317

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Complete Response Letter GlaxoSmithKline LLC (Dec 16, 2025)

Complete Response Letter LIB Therapeutics, Inc. (Dec 12, 2025)

Complete Response Letter Sandoz Inc. (Dec 9, 2025)

Complete Response Letter Alvotech USA Inc. (Nov 26, 2025)

Complete Response Letter Alvotech USA Inc. (Nov 24, 2025)

Complete Response Letter Accord Healthcare Inc. (Nov 6, 2025)

Complete Response Letter Biohaven Therapeutics, Ltd. (Nov 4, 2025)

Complete Response Letter Alvotech USA Inc. (Oct 31, 2025)

Complete Response Letter Shanghai Auzone Biological Technology Co., Ltd. (Oct 23, 2025)

Complete Response Letter GlaxoSmithKline LLC (Oct 23, 2025)

Complete Response Letter SYDNEXIS Inc. (Oct 22, 2025)

Complete Response Letter NeuroDerm, Ltd. (Oct 21, 2025)