FDA letter monthly archive

FDA Letters Issued in February 2024

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

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

CRLComplete Response Letter
Complete Response Letter Minerva Neurosciences, Inc (Feb 26, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, 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.
IssuedFeb 26, 2024
US FDA• roluperidone
CRLComplete Response Letter
Complete Response Letter Venatorx Pharmaceuticals, Inc. (Feb 22, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 22, 2024
US FDA• cefepime for injection and taniborbactam for injection, co-packaged for intravenous use
CRLComplete Response Letter
Complete Response Letter Xeris Pharmaceuticals, Inc. (Feb 9, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics, 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.
IssuedFeb 9, 2024
US FDA• GVOKE PFS / GVOKE HYPOPEN / GVOKE KIT

Complete Response Letter Minerva Neurosciences, Inc (Feb 26, 2024)

Complete Response Letter Venatorx Pharmaceuticals, Inc. (Feb 22, 2024)

Complete Response Letter Xeris Pharmaceuticals, Inc. (Feb 9, 2024)