Issued to Teva Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 27, 2016Application
NDA 505b1 • 208082
Product
AUSTEDO
Company
Teva Pharmaceuticals, Inc.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Teva Pharmaceuticals, Inc. on May 27, 2016.
NDA 208082 is the application under which FDA issued this complete response letter for AUSTEDO to Teva Pharmaceuticals, Inc.. The letter is dated May 27, 2016.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.