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恒瑞醫藥(600276.SH):獲得美國FDA批准文號
格隆匯 07-02 16:21

格隆匯7月2日丨恒瑞醫藥(600276.SH)公佈,公司收到美國食品藥品監督管理局(以下簡稱“FDA”)通知,公司向美國FDA申報的布比卡因脂質體注射液ANDA(簡略新藥申請,即美國仿製藥申請)已獲得批准,是首家在美國獲得該品種仿製藥批准的廠家。

布比卡因是臨牀上廣泛用於局部麻醉和術後鎮痛的酰胺類局部麻醉劑,相比於普通注射劑5至6小時的作用時間,布比卡因脂質體注射液可將鎮痛效果延長至數天,其採用先進的多囊脂質體藥物遞送系統,具有良好的緩釋效果,更有利於手術患者的疼痛管理,進而提高患者的生活質量。

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