上海医药(02607):醋酸艾司利卡西平片的ANDA获得美国FDA批准上市

智通财经网
Nov 10, 2025

智通财经APP讯,上海医药(02607)发布公告,近日,上海医药集团股份有限公司下属上海上药中西制药有限公司(上药中西) 收到美国食品药品监督管理局(美国 FDA)的通知,其关于醋酸艾司利卡西平片的简略新药申请(ANDA,即美国仿制药申请)已获得最终批准上市。醋酸艾司利卡西平片用于治疗4岁及以上患者的癫痫部分性发作,最早由Bial-Portela、Eisai和Dainippon Sumitomo...

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