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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

Feb 20, 2018PTC Therapeutics Receives Formal Dispute Resolution Request Decision from the FDA's Office of New Drugs
Oct 25, 2017PTC Therapeutics Receives Complete Response Letter for Ataluren's NDA
Mar  6, 2017PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy
Oct 17, 2016PTC Therapeutics Provides Regulatory Update on Translarna (ataluren) for Nonsense Mutation Duchenne Muscular Dystrophy
Feb 23, 2016PTC Receives Refuse to File Letter from FDA for Translarna (ataluren)
Oct 15, 2015PTC Announces Results from Phase 3 ACT DMD Clinical Trial of Translarna (ataluren) in Patients with Duchenne Muscular Dystrophy
Dec 23, 2014PTC Therapeutics Begins Rolling NDA Submission to the FDA for Translarna to Treat Duchenne Muscular Dystrophy
Jun  8, 2012Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
Jul  1, 2011Ataluren Phase 2 Data in Nonsense Mutation Cystic Fibrosis Published in the European Respiratory Journal
Oct 19, 2010Pivotal Data Presented at the World Muscle Society Congress Suggest Ataluren Slows the Loss of Walking Ability in Patients with Nonsense Mutation Duchenne/Becker Muscular Dystrophy
Mar  3, 2010PTC Therapeutics and Genzyme Corporation Announce Preliminary Results from the Phase 2b Clinical Trial of Ataluren for Nonsense Mutation Duchenne/Becker Muscular Dystrophy

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