華海藥業(600521.SH):製劑產品鹽酸哌甲酯片獲美國FDA批准文號
格隆匯7月27日丨華海藥業(600521.SH)公佈,近日,公司收到美國食品藥品監督管理局(以下簡稱“美國FDA”)的通知,公司向美國FDA申報的鹽酸哌甲酯片的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
鹽酸哌甲酯片主要用於治療腦功能輕微失調注意缺陷障礙(兒童多動綜合徵)等。鹽酸哌甲酯片由諾華研發,最早於1975年在美國上市。當前,美國境內,鹽酸哌甲酯片的主要生產廠商有Camber Pharm,Mallinckrodt等;國內生產廠商主要有華潤雙鶴藥業股份有限公司、通化仁民藥業股份有限公司等。2019年該藥品美國市場銷售額約5400萬美元(數據來源於IMS數據庫),公司尚未從相關數據庫查詢到國內鹽酸哌甲酯片的銷售數據。截至目前,公司在鹽酸哌甲酯片項目上已投入研發費用約840萬元人民幣。
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