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華海藥業(600521.SH):製劑產品富馬酸二甲酯緩釋膠囊獲得美國FDA批准文號
格隆匯 10-19 19:50

格隆匯10月19日丨華海藥業(600521.SH)公佈,近日,浙江華海藥業股份有限公司收到美國食品藥品監督管理局的通知,公司向美國FDA申報的富馬酸二甲酯緩釋膠囊的新藥簡略申請(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。

富馬酸二甲酯緩釋膠囊主要用於治療多發性硬化症。富馬酸二甲酯緩釋膠囊由Biogen研發,於2013年在美國上市,當前,美國境內,富馬酸二甲酯緩釋膠囊的主要生產廠商有Viatris、Reddy、Cipla等。2022年1月到8月該藥品美國市場銷售額約101,282,457美元(數據來源於IMS數據庫)。

截至目前,公司在富馬酸二甲酯緩釋膠囊項目上已投入研發費用約870萬元人民幣。

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