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健友股份(603707.SH):香港健友獲美國FDA注射用伏立康唑藥品註冊批件
格隆匯 05-10 17:10

格隆匯5月10日丨健友股份(603707.SH)公佈,公司子公司香港健友實業有限公司(簡稱“香港健友”)於近日收到美國食品藥品監督管理局簽發的注射用伏立康唑,200mg/瓶(ANDA號:214516)批准信。

適應症:治療成人和2歲及2歲以上兒童患者的下列真菌感染:侵襲性麴黴病、非中性粒細胞減少患者中的念珠菌血症、對氟康唑耐藥的念珠菌引起的嚴重侵襲性感染(包括克柔念珠菌)、由足放線病菌屬和鐮刀菌屬引起的嚴重感染。

截至目前,公司在注射用伏立康唑研發項目上已投入研發費用約人民幣2200.62萬元。

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