安科生物(300009.SZ):獲得阿莫西林顆粒生產註冊補充申請受理通知書
格隆匯1月21日丨安科生物(300009.SZ)公佈,近日,公司全資子公司安徽安科恆益藥業有限公司(“安科恆益”)收到國家藥品監督管理局下發的阿莫西林顆粒生產註冊補充申請《受理通知書》。
阿莫西林主要用於敏感菌(不產β內酰胺酶菌株)所致的成人與兒童的感染性疾病。
阿莫西林屬於青黴素類廣譜β-內酰胺類抗生素,對大多數致病的革蘭氏陽性菌及革蘭氏陰性菌均有強大的抑菌和殺菌作用,臨牀廣泛用於治療敏感菌所致上呼吸道感染、泌尿生殖道感染、皮膚軟組織感染、下呼吸道感染以及與其他藥物聯用根除幽門螺桿菌,且輕中度腎病患者無需調整劑量。被《中國成人社區獲得性肺炎診斷和治療(2016年版)》、《抗菌藥物臨牀應用指導原則(2015年版)》等權威指南和共識廣泛推薦。
阿莫西林膠囊原研公司為葛蘭素史克(GSK),阿莫西林顆粒屬於改劑型品種,本次獲受理的申請為仿製藥質量和療效一致性評價申請。
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