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Translarna Approval Status

  • FDA approved: No
  • Brand name: Translarna
  • Generic name: ataluren
  • Company: PTC Therapeutics, Inc.
  • Treatment for: Duchenne Muscular Dystrophy

Translarna (ataluren) is a protein restoration therapy in development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Development Status and FDA Approval Process for Translarna

Dec 23, 2014PTC Therapeutics Begins Rolling NDA Submission to the FDA for Translarna to Treat Duchenne Muscular Dystrophy

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