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雙成藥業(002693.SZ):依替巴肽注射液ANDA獲得美國FDA上市許可
格隆匯 09-09 16:29

格隆匯9月9日丨雙成藥業(002693.SZ)公佈,公司於近日收到美國食品和藥品監督管理局的通知,公司向美國FDA提交的依替巴肽注射液(規格20mg/10mL)的簡化新藥申請(“ANDA”)已獲得美國FDA的上市許可批准。美國FDA對公司遞交的依替巴肽注射液ANDA申報資料進行了全面技術審評,認可了申報信息的全面性和科學性。

依替巴肽注射液的適應症為抗凝血,用於急性冠狀動脈綜合徵患者,包括接受藥物治療的患者和進行經皮冠狀動脈介入術PCI的患者,以降低死亡或新發生心肌梗死的聯合終點發生率。用於進行經皮冠狀動脈介入術PCI的患者,包括進行冠狀動脈內支架置入術的患者,以降低死亡、新發生心肌梗死或需要緊急介入治療的聯合終點發生率。

依替巴肽注射液原研藥商品名為Integrilin®,廠家為ScheringCorp,於1998年5月18日獲美國FDA的上市批准;目前已在全球廣泛銷售。

截至公吿披露日,依替巴肽注射液累計研發投入金額為人民幣1642萬元(未經審計)。

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