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宣泰醫藥(688247.SH):達格列淨二甲雙胍緩釋片獲得美國FDA批准文號
格隆匯 05-12 15:37

格隆匯5月12日丨宣泰醫藥(688247.SH)公佈,收到美國食品藥品監督管理局(簡稱“美國FDA”)的通知,公司向美國FDA申報的達格列淨二甲雙胍緩釋片的簡略新藥申請(簡稱“ANDA”,即美國仿製藥申請)獲得暫時批准(TentativeApproval),達格列淨二甲雙胍緩釋片本次獲批的適應症為:改善成人2型糖尿病患者的血糖控制和降低以下風險:1)降低慢性腎臟病進展風險患者出現持續eGFR下降、終末期腎病、心血管死亡及因心力衰竭住院的風險;2)降低心力衰竭患者的心血管死亡、因心力衰竭住院及緊急心力衰竭就診風險;3)減少已確診心血管疾病或具有多重心血管危險因素的2型糖尿病患者因心力衰竭住院的風險。該藥品已於2024年9月獲得國家藥品監督管理局(NMPA)批准上市,為該品種國內首家獲批的仿製藥,用於治療2型糖尿病。

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