FDA letter date archive

FDA Letters Issued in 2023

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

Browse FDA approval and complete response letters issued in 2023. 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 CooperSurgical, Inc. (Dec 18, 2023)
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, 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 18, 2023
US FDA• PARAGARD T 380A
CRLComplete Response Letter
Complete Response Letter Checkpoint Therapeutics, Incorporated (Dec 15, 2023)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, 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 15, 2023
US FDA• UNLOXCYT
CRLComplete Response Letter
Complete Response Letter Alvotech USA Inc. (Oct 11, 2023)
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 11, 2023
US FDA• SELARSDI
CRLComplete Response Letter
Complete Response Letter Galderma R&D, LLC (Sep 29, 2023)
FDA's complete response letter contains source-text evidence related to 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.
IssuedSep 29, 2023
US FDA• BLA 761311
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Sep 28, 2023)
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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 28, 2023
US FDA• EBGLYSS
CRLComplete Response Letter
Complete Response Letter Botanix SB Inc. (Sep 22, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 22, 2023
US FDA• SOFDRA
CRLComplete Response Letter
Complete Response Letter ARS Pharmaceuticals, Inc. (Sep 19, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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.
IssuedSep 19, 2023
US FDA• NEFFY
CRLComplete Response Letter
Complete Response Letter Mesoblast, Inc. (Aug 1, 2023)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Statistical analysis, 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.
IssuedAug 1, 2023
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Citius Pharmaceuticals, Inc. (Jul 28, 2023)
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.
IssuedJul 28, 2023
US FDA• LYMPHIR
CRLComplete Response Letter
Complete Response Letter Impax Laboratories, LLC (Jun 30, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Bioequivalence and pharmacokinetics, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 30, 2023
US FDA• CREXONT
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jun 27, 2023)
FDA's complete response letter contains source-text evidence related to 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.
IssuedJun 27, 2023
US FDA• EYLEA HD
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
CRLComplete Response Letter
Complete Response Letter Ascendis Pharma Bone Diseases A/S (Apr 28, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, 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 28, 2023
US FDA• YORVIPATH
CRLComplete Response Letter
Complete Response Letter Novo Nordisk (Apr 24, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 24, 2023
US FDA• ALHEMO
CRLComplete Response Letter
Complete Response Letter Hugel, Inc (Apr 12, 2023)
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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 12, 2023
US FDA• LETYBO
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Mar 30, 2023)
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.
IssuedMar 30, 2023
US FDA• OMVOH
CRLComplete Response Letter
Complete Response Letter AbbVie Inc. (Mar 17, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Safety and adverse events, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 17, 2023
US FDA• VYALEV
CRLComplete Response Letter
Complete Response Letter Phathom Pharmaceuticals, Inc. (Feb 7, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 7, 2023
US FDA• VOQUEZNA
CRLComplete Response Letter
Complete Response Letter StemCyte, Inc. (Jan 20, 2023)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, 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 20, 2023
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Jan 18, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 18, 2023
US FDA• KISUNLA
CRLComplete Response Letter
Complete Response Letter Almatica Pharma, LLC (Jan 13, 2023)
FDA's complete response letter contains source-text evidence related to 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.
IssuedJan 13, 2023
US FDA• ZOLPIDEM TARTRATE
CRLComplete Response Letter
Complete Response Letter Liqmeds Worldwide Limited (Jan 6, 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.
IssuedJan 6, 2023
US FDA• MYHIBBIN

Complete Response Letter CooperSurgical, Inc. (Dec 18, 2023)

Complete Response Letter Checkpoint Therapeutics, Incorporated (Dec 15, 2023)

Complete Response Letter Alvotech USA Inc. (Oct 11, 2023)

Complete Response Letter Galderma R&D, LLC (Sep 29, 2023)

Complete Response Letter Eli Lilly and Company (Sep 28, 2023)

Complete Response Letter Botanix SB Inc. (Sep 22, 2023)

Complete Response Letter ARS Pharmaceuticals, Inc. (Sep 19, 2023)

Complete Response Letter Mesoblast, Inc. (Aug 1, 2023)

Complete Response Letter Citius Pharmaceuticals, Inc. (Jul 28, 2023)

Complete Response Letter Impax Laboratories, LLC (Jun 30, 2023)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jun 27, 2023)

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)

Complete Response Letter Ascendis Pharma Bone Diseases A/S (Apr 28, 2023)

Complete Response Letter Novo Nordisk (Apr 24, 2023)

Complete Response Letter Hugel, Inc (Apr 12, 2023)

Complete Response Letter Eli Lilly and Company (Mar 30, 2023)

Complete Response Letter AbbVie Inc. (Mar 17, 2023)

Complete Response Letter Phathom Pharmaceuticals, Inc. (Feb 7, 2023)

Complete Response Letter StemCyte, Inc. (Jan 20, 2023)

Complete Response Letter Eli Lilly and Company (Jan 18, 2023)

Complete Response Letter Almatica Pharma, LLC (Jan 13, 2023)

Complete Response Letter Liqmeds Worldwide Limited (Jan 6, 2023)