FDA letter monthly archive

FDA Letters Issued in November 2024

Name: FDA Letters Issued in November 2024
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in November 2024. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Applied Therapeutics, Inc. (Nov 27, 2024)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Nonclinical evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 27, 2024
US FDA• govorestat
CRLComplete Response Letter
Complete Response Letter Astellas Pharma US, Inc (Nov 15, 2024)
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.
IssuedNov 15, 2024
US FDA• IZERVAY
CRLComplete Response Letter
Complete Response Letter Lupin Limited (Biotech Division) (Nov 14, 2024)
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 14, 2024
US FDA• ARMLUPEG
CRLComplete Response Letter
Complete Response Letter Azurity Pharmaceuticals, Inc. (Nov 4, 2024)
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 4, 2024
US FDA• BRYNOVIN

Complete Response Letter Applied Therapeutics, Inc. (Nov 27, 2024)

Complete Response Letter Astellas Pharma US, Inc (Nov 15, 2024)

Complete Response Letter Lupin Limited (Biotech Division) (Nov 14, 2024)

Complete Response Letter Azurity Pharmaceuticals, Inc. (Nov 4, 2024)