Catalyst

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Eteplirsen PDUFA goal date extended by standard extension period of three months to May 26, 2016

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Additional Information

Additional Relevant Details FDA will require additional time to complete its review of the New Drug Application for eteplirsen, for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act date for eteplirsen has been extended to May 26, 2016. The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined.
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Catalyst Date
Occurred on:
May 25, 2016
Occurred Source:
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Related Keywords Eteplirsen, Pdufa, Delay, Advisory Committee