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健友股份:子公司亞硒酸注射液獲得美國FDA批准
健友股份公告,子公司健進制藥有限公司於近日收到美國食品藥品監督管理局簽發的亞硒酸注射液(600 mcg/10 mL)的ANDA批准通知(ANDA號:219472)。該藥品適用於需要腸外營養的成人與兒科患者,作為腸外營養液中硒的來源,用於當口服或腸內營養無法實施、不足或存在禁忌時。目前,美國境內共有5家亞硒酸注射液仿製藥獲批上市。公司在該項目上已投入研發費用約人民幣656.05萬元。新批准產品有望對公司經營業績產生積極影響。