Eteplirsen Approval Status
- FDA approved: No
- Generic name: eteplirsen
- Company: Sarepta Therapeutics, Inc.
- Treatment for: Duchenne Muscular Dystrophy
Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
Development Status and FDA Approval Process for eteplirsen
|Jun 6, 2016||Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDA|
|May 25, 2016||Sarepta Therapeutics Announces FDA Will Not Complete the Review of the Eteplirsen NDA By The PDUFA Date|
|Apr 25, 2016||Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy|
|Feb 8, 2016||Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen|
|Aug 25, 2015||Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping|
|Jun 29, 2015||Sarepta Therapeutics Completes NDA Submission to FDA for Eteplirsen|
|Oct 27, 2014||Sarepta Therapeutics Announces Regulatory Update on Eteplirsen|
|Apr 21, 2014||Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy|
|Nov 12, 2013||Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data|
|Jul 25, 2013||Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014|
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