永太科技(002326.SZ):美國永太製劑產品非諾貝特膠囊獲得美國FDA批准
格隆匯2月1日丨永太科技(002326.SZ)公佈,近日,浙江永太科技股份有限公司全資子公司永太科技(美國)有限公司(簡稱“美國永太”)收到美國食品藥品監督管理局(簡稱“FDA”)的通知,美國永太向美國FDA申報的非諾貝特膠囊簡略新藥申請(ANDA,即仿製藥申請)獲得批准。
非諾貝特是一種貝特類降血脂藥物,其作用機制主要是通過抑制膽固醇合成限速酶-微粒體羥基化酶的活性,使膽固醇合成減少;還能增加肝細胞對膽固醇的攝取和分解代謝,從而發揮降低血清膽固醇濃度的效果。非諾貝特膠囊,主要用於成人飲食控制療法效果不理想的高膽固醇血癥(IIa型),內源性高甘油三酯血癥,單純型(IV型)和混合型(IIb型和III型)。
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