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BRIEF-Acorda Therapeutics announced update on refusal to file letter that it received from U.S. FDA
September 27, 2017 / 11:29 AM / 21 days ago

BRIEF-Acorda Therapeutics announced update on refusal to file letter that it received from U.S. FDA

Sept 27 (Reuters) - Acorda Therapeutics Inc:

* Acorda Therapeutics ‍announced update on refusal to file letter that it received from U.S. FDA regarding its new drug application for Inbrija​

* Says it ‍has engaged in a constructive dialogue with FDA to determine most efficient path forward to resubmitting Inbrija NDA​

* Acorda Therapeutics - ‍based on interactions with FDA, co believes it can resubmit without a type a meeting, and therefore will not request such a meeting​

* Acorda Therapeutics - ‍reiterated that issues raised in RTF are addressable and that FDA has not requested or recommended additional clinical efficacy or safety studies​

* Says it ‍plans to resubmit NDA for ‍Inbrija​ as soon as possible​ Source text: (bit.ly/2wVLJJ8) Further company coverage:

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