Issued to Sarepta Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 19, 2019Application
NDA 505b1 • 211970
Product
VYONDYS 53
Company
Sarepta Therapeutics, Inc.
Review center
Other
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Nonclinical evidence, Clinical efficacy and substantial evidence. 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Sarepta Therapeutics, Inc. on August 19, 2019.
NDA 211970 is the application under which FDA issued this complete response letter for VYONDYS 53 to Sarepta Therapeutics, Inc.. It was reviewed by FDA Other. The letter is dated August 19, 2019.
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.