仙琚製藥(002332.SZ):非那雄胺片通過一致性評價
格隆匯 3 月 9日丨仙琚製藥(002332.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於非那雄胺片的《藥品補充申請批准通知書》(通知書編號:2021B00488、2021B00489),公司非那雄胺片通過仿製藥質量和療效一致性評價。
非那雄胺是一種4-氮雜甾體化合物,它是雄激素睾酮代謝成為二氫睾酮過程中的細胞內酶Ⅱ型5α還原酶的特異性抑制劑,最早由默克(Merck)公司研究開發。
非那雄胺片,規格:5mg,1992年6月首次獲得美國FDA上市許可,商品名為“PROSCAR”。主要用於:1.治療和控制良性前列腺增生(BPH)以及預防泌尿系統事件,降低發生急性尿瀦留的危險性,降低需進行經尿道切除前列腺(TURP)和前列腺切除術的危險性。2.可使肥大的前列腺縮小,改善尿流及改善前列腺增生有關的症狀。
非那雄胺片,規格:1mg,1997年12月首次獲得美國FDA上市許可,商品名為“PROPECIA”。主要用於治療男性禿髮(雄激素性禿髮),能促進頭髮生長並防止繼續脱髮。
公司非那雄胺片通過仿製藥質量和療效一致性評價,有利於提升產品市場競爭力,為公司後續藥品一致性評價工作積累經驗。
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