Eteplirsen Approval Status

  • FDA approved: No
  • Generic name: eteplirsen
  • Treatment for: Duchenne Muscular Dystrophy

Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD).

FDA Approval Status for eteplirsen

DateArticle
Apr 21, 2014Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy
Nov 12, 2013Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data
Jul 25, 2013Sarepta 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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