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09-14

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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