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 49-60 of 1503 letters

CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories SA (Oct 16, 2025)
FDA's complete response letter contains source-text evidence related to 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 16, 2025
US FDA• BLA 761376
CRLComplete Response Letter
Complete Response Letter AstraZeneca Pharmaceuticals LP (Oct 10, 2025)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 10, 2025
US FDA• SAPHNELO
CRLComplete Response Letter
Complete Response Letter Xspray Pharma AB (Oct 7, 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 7, 2025
US FDA• NDA 216195
CRLComplete Response Letter
Complete Response Letter Sentynl Therapeutics, Inc. (Sep 30, 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.
IssuedSep 30, 2025
US FDA• ZYCUBO
CRLComplete Response Letter
Complete Response Letter Biogen, Inc. (Sep 22, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 22, 2025
US FDA• SPINRAZA
CRLComplete Response Letter
Complete Response Letter Scholar Rock, Inc. (Sep 22, 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.
IssuedSep 22, 2025
US FDA• BLA 761463
CRLComplete Response Letter
Complete Response Letter Outlook Therapeutics, Inc. (Aug 27, 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.
IssuedAug 27, 2025
US FDA• LYTENAVA
CRLComplete Response Letter
Complete Response Letter Vyluma, Inc. (Aug 27, 2025)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 27, 2025
US FDA• NDA 217711
CRLComplete Response Letter
Complete Response Letter Saol International Development Limited (Aug 27, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 27, 2025
US FDA• NDA 218679
CRLComplete Response Letter
Complete Response Letter PTC Therapeutics, Inc. (Aug 18, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 18, 2025
US FDA• vatiquinone
CRLComplete Response Letter
Complete Response Letter Immedica Pharma AB (Aug 6, 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.
IssuedAug 6, 2025
US FDA• LOARGYS
CRLComplete Response Letter
Complete Response Letter Accord BioPharma, Inc. (Aug 5, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 5, 2025
US FDA• ENNUMO

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Complete Response Letter Dr. Reddy’s Laboratories SA (Oct 16, 2025)

Complete Response Letter AstraZeneca Pharmaceuticals LP (Oct 10, 2025)

Complete Response Letter Xspray Pharma AB (Oct 7, 2025)

Complete Response Letter Sentynl Therapeutics, Inc. (Sep 30, 2025)

Complete Response Letter Biogen, Inc. (Sep 22, 2025)

Complete Response Letter Scholar Rock, Inc. (Sep 22, 2025)

Complete Response Letter Outlook Therapeutics, Inc. (Aug 27, 2025)

Complete Response Letter Vyluma, Inc. (Aug 27, 2025)

Complete Response Letter Saol International Development Limited (Aug 27, 2025)

Complete Response Letter PTC Therapeutics, Inc. (Aug 18, 2025)

Complete Response Letter Immedica Pharma AB (Aug 6, 2025)

Complete Response Letter Accord BioPharma, Inc. (Aug 5, 2025)