*ST双成(002693.SZ)：注射用紫杉醇(白蛋白结合型)ANDA获美国FDA上市许可

智通财经2025-05-16

智通财经APP讯，*ST双成(002693.SZ)公告，公司近日收到美国食品和药品监督管理局(简称“FDA”)的通知，公司向美国FDA提交的注射用紫杉醇(白蛋白结合型)简略新药申请(简称“ANDA”)已获得美国FDA的上市许可批准。美国FDA对公司递交的注射用紫杉醇(白蛋白结合型)ANDA申报资料进行了全面技术审评，认定公司的产品与原研药品生物等效和疗效等效。公告显示，注射用紫杉醇(白蛋白结合型)...

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