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Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

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Additional Information

Additional Relevant Details The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen on April 25, 2016. The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the eteplirsen is May 26, 2016.
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Catalyst Date
Occurred on:
Apr 25, 2016
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Related Keywords Fda Ad-comm, Advisory Committee Meeting, Eteplirsen, Duchenne Muscular Dystrophy, Skipping Exon-51