FDA letter date archive

FDA Letters Issued in 2017

Name: FDA Letters Issued in 2017
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA approval and complete response letters issued in 2017. 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 AFT Pharmaceuticals, Ltd. (Dec 22, 2017)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, 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 22, 2017
US FDA• COMBOGESIC
CRLComplete Response Letter
Complete Response Letter Agile Therapeutics, Inc. (Dec 21, 2017)
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, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 21, 2017
US FDA• TWIRLA
CRLComplete Response Letter
Complete Response Letter Mylan Laboratories Limited (Dec 6, 2017)
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.
IssuedDec 6, 2017
US FDA• ACETAMINOPHEN
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals USA, Inc. (Oct 26, 2017)
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.
IssuedOct 26, 2017
US FDA• CLIGAVYX
CRLComplete Response Letter
Complete Response Letter Antares Pharma, Inc. (Oct 20, 2017)
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 20, 2017
US FDA• XYOSTED (AUTOINJECTOR)
CRLComplete Response Letter
Complete Response Letter AcelRx Pharmaceuticals, Inc. (Oct 11, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, 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.
IssuedOct 11, 2017
US FDA• DSUVIA
CRLComplete Response Letter
Complete Response Letter B. Braun Medical, Inc. (Sep 28, 2017)
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.
IssuedSep 28, 2017
US FDA• ACETAMINOPHEN
CRLComplete Response Letter
Complete Response Letter Actavis, L.L.C. (Sep 26, 2017)
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.
IssuedSep 26, 2017
US FDA• PEMETREXED
CRLComplete Response Letter
Complete Response Letter Astellas Pharma US, Inc. (Aug 28, 2017)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 28, 2017
US FDA• VESICARE LS
CRLComplete Response Letter
Complete Response Letter Ironshore Pharmaceuticals & Development, Inc. (Jul 28, 2017)
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.
IssuedJul 28, 2017
US FDA• JORNAY PM
CRLComplete Response Letter
Complete Response Letter Amgen Inc. (Jul 13, 2017)
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.
IssuedJul 13, 2017
US FDA• EVENITY
CRLComplete Response Letter
Complete Response Letter Ocular Therapeutix, Inc. (Jul 10, 2017)
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.
IssuedJul 10, 2017
US FDA• DEXTENZA
CRLComplete Response Letter
Complete Response Letter Coherus BioSciences, Inc. (Jun 9, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Statistical analysis, 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.
IssuedJun 9, 2017
US FDA• UDENYCA
CRLComplete Response Letter
Complete Response Letter United Therapeutics Corporation (Jun 2, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 2, 2017
US FDA• REMODULIN
CRLComplete Response Letter
Complete Response Letter TherapeuticsMD, Inc. (May 5, 2017)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, 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.
IssuedMay 5, 2017
US FDA• IMVEXXY
CRLComplete Response Letter
Complete Response Letter Institut Biochimique SA (IBSA) (Mar 24, 2017)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 24, 2017
US FDA• LICART
CRLComplete Response Letter
Complete Response Letter Sun Pharma Advanced Research Company Limited (Mar 22, 2017)
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 22, 2017
US FDA• ELEPSIA XR
CRLComplete Response Letter
Complete Response Letter Amphastar Pharmaceuticals, Inc. (Feb 17, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, 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.
IssuedFeb 17, 2017
US FDA• REXTOVY
CRLComplete Response Letter
Complete Response Letter Metacel Pharmaceuticals, LLC (Jan 11, 2017)
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 11, 2017
US FDA• OZOBAX / OZOBAX DS

Complete Response Letter AFT Pharmaceuticals, Ltd. (Dec 22, 2017)

Complete Response Letter Agile Therapeutics, Inc. (Dec 21, 2017)

Complete Response Letter Mylan Laboratories Limited (Dec 6, 2017)

Complete Response Letter Teva Pharmaceuticals USA, Inc. (Oct 26, 2017)

Complete Response Letter Antares Pharma, Inc. (Oct 20, 2017)

Complete Response Letter AcelRx Pharmaceuticals, Inc. (Oct 11, 2017)

Complete Response Letter B. Braun Medical, Inc. (Sep 28, 2017)

Complete Response Letter Actavis, L.L.C. (Sep 26, 2017)

Complete Response Letter Astellas Pharma US, Inc. (Aug 28, 2017)

Complete Response Letter Ironshore Pharmaceuticals & Development, Inc. (Jul 28, 2017)

Complete Response Letter Amgen Inc. (Jul 13, 2017)

Complete Response Letter Ocular Therapeutix, Inc. (Jul 10, 2017)

Complete Response Letter Coherus BioSciences, Inc. (Jun 9, 2017)

Complete Response Letter United Therapeutics Corporation (Jun 2, 2017)

Complete Response Letter TherapeuticsMD, Inc. (May 5, 2017)

Complete Response Letter Institut Biochimique SA (IBSA) (Mar 24, 2017)

Complete Response Letter Sun Pharma Advanced Research Company Limited (Mar 22, 2017)

Complete Response Letter Amphastar Pharmaceuticals, Inc. (Feb 17, 2017)

Complete Response Letter Metacel Pharmaceuticals, LLC (Jan 11, 2017)