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Zevra Therapeutics Says FDA Has Extended Review Period For New Drug Application For Arimoclomol As Treatment For Niemann-Pick Disease Type C

Author: Benzinga Newsdesk | March 04, 2024 08:33am

In addition, the FDA has set a new Prescription Drug User Fee Act ("PDUFA") action date of September 21, 2024, and has re-affirmed its intent to present the resubmission for discussion at an advisory committee meeting to be scheduled. As part of the ongoing review, Zevra received notification from the FDA that it required more time to review the additional analyses provided by the Company in responses to recent information requests generated from the FDA's review. 

Posted In: ZVRA


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