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

Further information

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