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健友股份(603707.SH):獲得米力農注射液USP美國註冊批件
格隆匯 03-25 15:49

格隆匯3月25日丨健友股份(603707.SH)公佈,公司於近日到美國食品藥品監督管理局(“美國FDA)簽發的米力農注射液USPANDA批准通知(ANDA號:211671)。

米力農是一種磷酸二酯酶抑制劑類強心藥,有擴張血管平滑肌的作用,能降低心臟負荷,還能極好地改善腎臟和肌肉供血,主要用於對洋地黃、利尿劑、血管擴張劑治療無效或效果欠佳的各種原因引起的急、慢性頑固性充血性心力衰竭。

截至目前,公司在米力農注射液USP研發項目上已投入研發費用約人民幣1333.25萬元。

公司米力農注射液USP獲得美國FDA批准,標誌着公司已具備在美國市銷售該藥品資格,不但豐富了公司的產品線,同時表明公司在美國市場又邁入了一大步,提升了公司整體的市場競爭力,有望對公司經營業績產生積極影響。

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