智通财经APP讯,上海医药(601607.SH)发布公告,近日,公司下属常州制药厂有限公司(“常州制药厂”)收到美国食品药品监督管理局(以下简称“美国FDA”)的通知,其关于利伐沙班片(基本情况详阅正文,以下简称“该药品”)的简略新药申请(“ANDA”,即美国仿制药申请)已获得批准(“Approval”)。
利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险;用于治疗和预防深静脉血栓形成(DVT);用于治疗肺栓塞(PE);用于预防急性病患者静脉血栓栓塞(VTE)等。利伐沙班片最早由BAYER和JANSSEN联合研发并于2011年在美国上市。2021年12月,常州制药厂就该药品向美国FDA提出ANDA申请,并于近日获得批准文号。截至本公告日,公司针对该药品已投入研发费用约人民币820万元。
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