FDA letter monthly archive

FDA Letters Issued in August 2025

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

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

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

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)