FDA letter monthly archive

FDA Letters Issued in February 2022

Name: FDA Letters Issued in February 2022
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in February 2022. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Gilead Sciences, Inc. (Feb 28, 2022)
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.
IssuedFeb 28, 2022
US FDA• SUNLENCA
CRLComplete Response Letter
Complete Response Letter Amryt Pharmaceuticals DAC (Feb 26, 2022)
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.
IssuedFeb 26, 2022
US FDA• FILSUVEZ
CRLComplete Response Letter
Complete Response Letter Green Cross Corporation (Feb 25, 2022)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 25, 2022
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Shandong Luye Pharmaceutical Co., Ltd. (Feb 18, 2022)
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, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 18, 2022
US FDA• RYKINDO

Complete Response Letter Gilead Sciences, Inc. (Feb 28, 2022)

Complete Response Letter Amryt Pharmaceuticals DAC (Feb 26, 2022)

Complete Response Letter Green Cross Corporation (Feb 25, 2022)

Complete Response Letter Shandong Luye Pharmaceutical Co., Ltd. (Feb 18, 2022)