現代製藥(600420.SH):克拉黴素片通過仿製藥一致性評價
格隆匯6月12日丨現代製藥(600420.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的克拉黴素片《藥品補充申請批件》,批准該藥品通過仿製藥質量和療效一致性評價。
克拉黴素片適用於克拉黴素敏感菌所引起的感染:鼻炎感染、下呼吸道感染、皮膚軟組織感染、急性中耳炎、肺炎支原體肺炎、沙眼衣原體引起的尿道炎及宮頸炎,也用於軍團菌感染或與其他藥物聯合用於鳥分支桿菌感染、幽門螺旋桿菌感染的治療。
根據米內網數據庫顯示,克拉黴素2019年在全國城市樣本公立醫院的銷售額為8.19億元。
CDE網站顯示,目前克拉黴素片(0.25g)通過一致性評價的有浙江貝得藥業有限公司。國內擁有克拉黴素片(0.25g)藥品生產批文的還有麗珠集團麗珠製藥廠和杭州中美華東製藥有限公司等。截至目前,公司用於開展克拉黴素片(0.25g)一致性評價累計研發投入約人民幣1273.23萬元(未經審計)。
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