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FDA Accepts Supernus Pharmaceuticals' Resubmission for Parkinson's Treatment Device, Decision Expected by February 2025

Author: Benzinga Newsdesk | August 19, 2024 07:03am

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease (PD). The resubmission is now considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.

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