FDA Accepts Supernus Pharmaceuticals' Resubmission for Parkinson's Treatment Device, Decision Expected by February 2025
FDA Accepts Supernus Pharmaceuticals' Resubmission for Parkinson's Treatment Device, Decision Expected by February 2025
FDA接受Supernus Pharmaceuticals的帕金森治疗设备的重新提交，决定预计2025年2月公布。
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.
超能医药公司（纳斯达克代码：SUPN）是一家专注于开发和商业化中枢神经系统（CNS）疾病治疗产品的生物制药公司。今天宣布，美国食品和药物管理局（FDA）已确认其阿泼莫啡输注装置（SPN-830）的新药申请（NDA）重新提交，以连续治疗帕金森氏病（PD）的运动波动（OFF episodes）。重新提交现已被视为已提交，目标用户费用截止日期（PDUFA日期）为2025年2月1日。
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