華潤醫藥(03320.HK)旗下潤生藥業哮喘仿製藥申請獲美國FDA受理並進入實質審查
華潤醫藥(03320.HK)公布,旗下子公司華潤三九聯合華潤醫藥產業投資基金共同參股的潤生藥業,向美國FDA遞交的Advair Diskus仿製藥ANDA申請,FDA已經受理並進入實質審查。作為同類藥品不超過3家的品種,FDA給予了該申請優先審評資格。
作為潤生藥業首個核心產品,沙美特羅替卡松粉吸入劑為對GSK的Advair Diskus高端仿製藥。該藥用於治療4歲及以上患者的哮喘以及氣流阻塞的維持治療和減少慢性阻塞性肺病患者的急性發作。
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