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Drug Approval Package: Vyondys 53 (golodirsen)

Company: Sarepta Therapeutics, Inc.
Application Number: 211970
Approval Date: 12/12/2019

Drugs@FDA information available about Vyondys 53

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

Approval Letter(s) (PDF)
Printed Labeling (PDF)

FDA Application Review Files

Other Action Letters (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Clinical Review(s) (PDF)
Product Quality Review(s) (PDF)
Non-Clinical Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s)
Clinical Pharmacology Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: January 21, 2020

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

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