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BRIEF-Acorda receives refusal to file letter from FDA for Inbrija maketing application
August 29, 2017 / 11:19 AM / a month ago

BRIEF-Acorda receives refusal to file letter from FDA for Inbrija maketing application

Aug 29 (Reuters) - Acorda Therapeutics Inc

* Acorda receives refusal to file letter from FDA for Inbrija™ (CVT-301, Levodopa inhalation powder) new drug application

* Acorda Therapeutics - ‍upon prelim review, FDA determined NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review​

* Acorda Therapeutics Inc - ‍FDA has not requested or recommended additional clinical efficacy or safety studies​

* Acorda - Will seek immediate guidance, including a type a meeting with FDA

* Acorda Therapeutics Inc - ‍FDA also requested additional information at resubmission, which was not part of basis for RTF​

* Acorda Therapeutics Inc - ‍FDA specified two reasons for refusal to file: first, date when manufacturing site would be ready for inspection​

* Acorda Therapeutics Inc - ‍FDA specified two reasons for refusal to file: second, a question regarding submission of drug master production record​

* Acorda - To seek meeting with FDA to respond to issues which co believes addressable, to seek clarification of what additional information is required​ Source text for Eikon: Further company coverage:

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