健友股份:獲得美國度骨化醇注射液藥品註冊批件
格隆匯2月12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(“美國FDA”)簽發的度骨化醇注射液ANDA 批准通知(ANDA號:211670)。
度骨化醇注射液用於治療慢性腎臟疾病透析患者繼發性甲狀旁腺功能亢進。
公司度骨化醇注射液獲得美國FDA批准,標誌着公司已具備在美國市場銷售該藥品資格,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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