FDA letter monthly archive

FDA Letters in October 2021

Name: FDA Letters in October 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued or posted in October 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Marius Pharmaceuticals, LLC (Oct 22, 2021)
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, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 22, 2021
US FDA• KYZATREX
CRLComplete Response Letter
Complete Response Letter Eyenovia, Inc. (Oct 22, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Facility inspection and CGMP compliance, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 22, 2021
US FDA• MYDCOMBI
CRLComplete Response Letter
Complete Response Letter Omeros Corporation (Oct 15, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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.
IssuedOct 15, 2021
US FDA• YARTEMLEA
CRLComplete Response Letter
Complete Response Letter United Therapeutics Corp. (Oct 15, 2021)
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.
IssuedOct 15, 2021
US FDA• TYVASO DPI
CRLComplete Response Letter
Complete Response Letter Revance Therapeutics, Inc. (Oct 14, 2021)
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.
IssuedOct 14, 2021
US FDA• DAXXIFY
CRLComplete Response Letter
Complete Response Letter Polarean Inc. (Oct 5, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 5, 2021
US FDA• XENOVIEW

Complete Response Letter Marius Pharmaceuticals, LLC (Oct 22, 2021)

Complete Response Letter Eyenovia, Inc. (Oct 22, 2021)

Complete Response Letter Omeros Corporation (Oct 15, 2021)

Complete Response Letter United Therapeutics Corp. (Oct 15, 2021)

Complete Response Letter Revance Therapeutics, Inc. (Oct 14, 2021)

Complete Response Letter Polarean Inc. (Oct 5, 2021)