FDA letter monthly archive

FDA Letters Issued in October 2017

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

Browse FDA application-action, complete response, and warning letters issued in October 2017. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

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

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)