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