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Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C

Por: RTTNews Health January 08, 2024

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Rare disease therapeutics company Zevra Therapeutics, Inc. () announced Monday that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.Under the Prescription Drug User Fee Act (PDUFA), the FDA has deemed the arimoclomol NDA resubmission to be a Class II complete response which... + full article



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