FDA letter monthly archive

FDA Letters Issued in December 2025

Name: FDA Letters Issued in December 2025
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in December 2025. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories, Inc. (Dec 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.
IssuedDec 30, 2025
US FDA• BLA 761471
CRLComplete Response Letter
Complete Response Letter Outlook Therapeutics, Inc. (Dec 30, 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 30, 2025
US FDA• LYTENAVA
CRLComplete Response Letter
Complete Response Letter Genzyme Corporation (Dec 23, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 23, 2025
US FDA• NDA 219624
CRLComplete Response Letter
Complete Response Letter MedicaSafe, Inc. (Dec 22, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 22, 2025
US FDA• NDA 220184
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

Complete Response Letter Dr. Reddy’s Laboratories, Inc. (Dec 30, 2025)

Complete Response Letter Outlook Therapeutics, Inc. (Dec 30, 2025)

Complete Response Letter Genzyme Corporation (Dec 23, 2025)

Complete Response Letter MedicaSafe, Inc. (Dec 22, 2025)

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)