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健友股份(603707.SH)獲得美國依諾肝素鈉注射液USP藥品註冊批件
格隆匯 12-01 22:30

格隆匯12月1日丨健友股份(603707.SH)公佈,公司於近日收到美國食品藥品監督管理局(以下簡稱"美國 FDA")簽發的依諾肝素鈉注射液USP ANDA 批准通知。

依諾肝素鈉注射液USP主要用於預防靜脈血栓栓塞性疾病(預防靜脈內血栓形成),特別是與骨科或普外手術有關的血栓形成。治療已形成的深靜脈血栓,伴或不伴有肺栓塞,臨牀症狀不嚴重,不包括需要外科手術或溶栓劑治療的肺栓塞。治療不穩定性心絞痛及非Q波心肌梗死,與阿司匹林合用。用於血液透析體外循環中,防止血栓形成。

公告稱,2014年5月30日,公司就該藥品的30mg/0,3mL; 40mg/0,4mL; 60mg/0,6mL; 80mg/0,8mL; 100mg/mL; 120mg/0,8mL; 150mg/mL七個規格,首次向美國FDA提交註冊申請,並於2014年12月12日獲得受理,公司於2019年11月29日收到美國 FDA 最終批准。截至目前,公司在該產品研發項目已投入研發費用約人民幣 12,296.60萬元。 

公司依諾肝素鈉注射液USP獲得美國FDA批准,標誌着公司已具備在美國市場銷售該藥品資格,擴大了公司產品市場範圍,提升了公司整體市場競爭力,有望對公司經營業績產生積極影響。

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