25.05.2016 13:08:15

Sarepta Says FDA Will Not Complete Review Of Eteplirsen NDA By PDUFA Date

(RTTNews) - Sarepta Therapeutics Inc. (SRPT) said that the U.S. Food and Drug Administration has notified the Company that they are continuing their review and internal discussions related to pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act or PDUFA goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

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