FDA letter monthly archive

FDA Letters Issued in December 2024

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

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

CRLComplete Response Letter
Complete Response Letter Hikma Pharmaceuticals USA Inc. (Dec 23, 2024)
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.
IssuedDec 23, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Lexicon Pharmaceuticals, Inc. (Dec 20, 2024)
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, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 20, 2024
US FDA• sotagliflozin
CRLComplete Response Letter
Complete Response Letter Zealand Pharma US, Inc. (Dec 19, 2024)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, 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 19, 2024
US FDA• glepaglutide
CRLComplete Response Letter
Complete Response Letter CELLTRION, Inc. (Dec 17, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, 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 17, 2024
US FDA• STEQEYMA
CRLComplete Response Letter
Complete Response Letter Janssen Biotech, Inc. (Dec 13, 2024)
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 13, 2024
US FDA• RYBREVANT FASPRO
CRLComplete Response Letter
Complete Response Letter Meitheal Pharmaceuticals Inc. (Dec 11, 2024)
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 11, 2024
US FDA• CONTEPO
CRLComplete Response Letter
Complete Response Letter Fresenius Kabi USA, LLC (Dec 11, 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.
IssuedDec 11, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Sandoz Inc. (Dec 5, 2024)
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 5, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Accord Healthcare Inc. (Dec 5, 2024)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 5, 2024
US FDA• Unknown

Complete Response Letter Hikma Pharmaceuticals USA Inc. (Dec 23, 2024)

Complete Response Letter Lexicon Pharmaceuticals, Inc. (Dec 20, 2024)

Complete Response Letter Zealand Pharma US, Inc. (Dec 19, 2024)

Complete Response Letter CELLTRION, Inc. (Dec 17, 2024)

Complete Response Letter Janssen Biotech, Inc. (Dec 13, 2024)

Complete Response Letter Meitheal Pharmaceuticals Inc. (Dec 11, 2024)

Complete Response Letter Fresenius Kabi USA, LLC (Dec 11, 2024)

Complete Response Letter Sandoz Inc. (Dec 5, 2024)

Complete Response Letter Accord Healthcare Inc. (Dec 5, 2024)