PTC Therapeutics (PTCT) Says FDA Denied First Appeal of the Refuse to File Letter
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PTC Therapeutics Provides Regulatory Update on Translarna™ (ataluren) for Nonsense Mutation Duchenne Muscular Dystrophy
October 17, 2016 8:00 AM EDTSOUTH PLAINFIELD, N.J., Oct. 17, 2016 /PRNewswire/ --Â PTC Therapeutics, Inc. (NASDAQ: PTCT) today provided a regulatory update on Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
U.S. regulatory update
PTC Therapeutics announced today that at the end of last week, the Office of Drug Evaluation I (ODE-I) of the U.S. Food and Drug Administration (FDA) denied the company's first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding PTC's New Drug Application (NDA)... More