健友股份(603707.SH)獲得美國肝素鈉注射液USP藥品註冊批件
格隆匯4月3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”)簽發的肝素鈉注射液USPANDA批准通知(ANDA號:212060)。
藥品名稱:肝素鈉注射液USP;適應症:肝素鈉注射液USP主要用於抗凝、抗血栓等症狀的治療,用於防治血栓形成或栓塞性疾病(如心肌梗塞、血栓性靜脈炎、肺栓塞等);各種原因引起的瀰漫性血管內凝血(DIC);也用於血液透析、體外循環、導管術、微血管手術等操作中及某些血液標本或器械的抗凝處理。劑型:注射液;規格:5,000 Units/0.5 mL Single-Dose。
公司肝素鈉注射液USP(西林瓶)9個規格先前已全部獲得FDA批准並已在美國上市形成銷售,此次為預充針系列中的首個規格獲批,新批准產品近期也將安排在美國上市銷售,有望對公司今年經營業績產生積極影響。
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