普洛药业(000739.SZ)子公司布立西坦片获得美国FDA批准

智通财经
Sep 14

智通财经APP讯,普洛药业(000739.SZ)发布公告,近日,公司全资子公司浙江普洛巨泰药业有限公司(简称“巨泰药业”)收到美国食品药品监督管理局(简称“美国FDA”)的通知,巨泰药业向美国FDA申报的布立西坦片简略新药申请(ANDA,即美国仿制药申请)已获得批准。

布立西坦片是一种新型抗癫痫药物,为第二代抗癫痫药左乙拉西坦的衍生物,主要用于治疗部分性发作及相关癫痫类型。据相关数据显示,2025年布立西坦片在美国市场的销售额约为8.23亿美元。

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