宣泰医药(688247.SH)：西格列汀二甲双胍缓释片获美国FDA批准文号

智通财经2025-10-20

智通财经APP讯，宣泰医药(688247.SH)公告，公司收到美国食品药品监督管理局(“FDA”)的通知，公司向美国FDA申报的西格列汀二甲双胍缓释片的简略新药申请(简称“ANDA””，即美国仿制药申请)获得暂时批准。西格列汀二甲双胍缓释片由MERCK SHARPDOHME公司开发，于2012年2月在美国获批上市，适用于改善成人2型糖尿病患者的血糖控制。

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