FDA letter date archive

FDA Letters Issued in 2022

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

Browse FDA approval and complete response letters issued in 2022. This archive groups source-linked letters by issue date so regulatory teams can review decisions and deficiency patterns over time.

CRLComplete Response Letter
Complete Response Letter lpsen Biopharmaceuticals Inc. (Dec 23, 2022)
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 23, 2022
US FDA• SOHONOS
CRLComplete Response Letter
Complete Response Letter Alvotech USA, Inc. (Dec 20, 2022)
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 20, 2022
US FDA• SIMLANDI
CRLComplete Response Letter
Complete Response Letter Spes Pharmaceuticals Inc. (Oct 19, 2022)
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 19, 2022
US FDA• FOCINVEZ
CRLComplete Response Letter
Complete Response Letter CorMedix Inc. (Aug 4, 2022)
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.
IssuedAug 4, 2022
US FDA• DEFENCATH
CRLComplete Response Letter
Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 30, 2022
US FDA• COMBOGESIC IV
CRLComplete Response Letter
Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)
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.
IssuedJun 15, 2022
US FDA• OLPRUVA
CRLComplete Response Letter
Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)
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.
IssuedJun 6, 2022
US FDA• SUFLAVE
CRLComplete Response Letter
Complete Response Letter UGB, Inc. (May 12, 2022)
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.
IssuedMay 12, 2022
US FDA• BIMZELX
CRLComplete Response Letter
Complete Response Letter Coherus BioSciences, Inc. (Apr 29, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 29, 2022
US FDA• LOQTORZI
CRLComplete Response Letter
Complete Response Letter Teva Neuroscience, Inc. (Apr 15, 2022)
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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 15, 2022
US FDA• UZEDY
CRLComplete Response Letter
Complete Response Letter Akebia Therapeutics, Inc. (Mar 29, 2022)
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.
IssuedMar 29, 2022
US FDA• VAFSEO
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
CRLComplete Response Letter
Complete Response Letter Pfizer Ireland Pharmaceuticals (Jan 21, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, 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.
IssuedJan 21, 2022
US FDA• NGENLA

Complete Response Letter lpsen Biopharmaceuticals Inc. (Dec 23, 2022)

Complete Response Letter Alvotech USA, Inc. (Dec 20, 2022)

Complete Response Letter Spes Pharmaceuticals Inc. (Oct 19, 2022)

Complete Response Letter CorMedix Inc. (Aug 4, 2022)

Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)

Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)

Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)

Complete Response Letter UGB, Inc. (May 12, 2022)

Complete Response Letter Coherus BioSciences, Inc. (Apr 29, 2022)

Complete Response Letter Teva Neuroscience, Inc. (Apr 15, 2022)

Complete Response Letter Akebia Therapeutics, Inc. (Mar 29, 2022)

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)

Complete Response Letter Pfizer Ireland Pharmaceuticals (Jan 21, 2022)