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www.fdanews.com/articles/175512-fda-slaps-ptc-therapeutics-with-refusal-to-file-letter

FDA Slaps PTC Therapeutics With Refusal to File Letter

February 29, 2016

The FDA has delivered PTC Therapeutics a stinging rebuke, sending the company a refuse to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy.

According to the drugmaker, the agency said in the letter that the application was not sufficiently complete to permit a substantive review. The company says it is reviewing the letter to determine next steps.