Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

PDUFA Target Action Date of February 1, 2025

ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- 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.