FDA letter monthly archive

FDA Letters Issued in March 2025

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

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

CRLComplete Response Letter
Complete Response Letter Milestone Pharmaceuticals USA, Inc. (Mar 27, 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.
IssuedMar 27, 2025
US FDA• CARDAMYST
CRLComplete Response Letter
Complete Response Letter CELLTRION, Inc. (Mar 26, 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.
IssuedMar 26, 2025
US FDA• EYDENZELT
CRLComplete Response Letter
Complete Response Letter Jiangsu Hengrui Pharmaceuticals Co., Ltd (Mar 20, 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.
IssuedMar 20, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Elevar Therapeutics, Inc. (Mar 20, 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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 20, 2025
US FDA• rivoceranib tablets
CRLComplete Response Letter
Complete Response Letter Accord BioPharma Inc. (Mar 13, 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.
IssuedMar 13, 2025
US FDA• OSVYRTI / JUBEREQ
CRLComplete Response Letter
Complete Response Letter Seikagaku Corporation (Mar 11, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 11, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Laurus Generics, Inc. (Mar 10, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 10, 2025
US FDA• Unknown

Complete Response Letter Milestone Pharmaceuticals USA, Inc. (Mar 27, 2025)

Complete Response Letter CELLTRION, Inc. (Mar 26, 2025)

Complete Response Letter Jiangsu Hengrui Pharmaceuticals Co., Ltd (Mar 20, 2025)

Complete Response Letter Elevar Therapeutics, Inc. (Mar 20, 2025)

Complete Response Letter Accord BioPharma Inc. (Mar 13, 2025)

Complete Response Letter Seikagaku Corporation (Mar 11, 2025)

Complete Response Letter Laurus Generics, Inc. (Mar 10, 2025)