FDA letter monthly archive

FDA Letters Issued in May 2023

Name: FDA Letters Issued in May 2023
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in May 2023. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Fresenius Kabi USA, LLC (May 31, 2023)
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.
IssuedMay 31, 2023
US FDA• TYENNE
CRLComplete Response Letter
Complete Response Letter AOP Orphan Pharmaceuticals GmbH (May 31, 2023)
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.
IssuedMay 31, 2023
US FDA• RAPIBLYK
CRLComplete Response Letter
Complete Response Letter Galephar Pharmaceutical Research Inc. (May 5, 2023)
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, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 5, 2023
US FDA• LEGUBETI

Complete Response Letter Fresenius Kabi USA, LLC (May 31, 2023)

Complete Response Letter AOP Orphan Pharmaceuticals GmbH (May 31, 2023)

Complete Response Letter Galephar Pharmaceutical Research Inc. (May 5, 2023)