安科生物(300009.SZ):安科恆益阿莫西林顆粒通過仿製藥一致性評價
格隆匯3月21日丨安科生物(300009.SZ)公佈,公司全資孫公司安科恆益收到國家藥品監督管理局下發的《藥品補充申請批准通知書》,安科恆益“阿莫西林顆粒”通過仿製藥質量和療效一致性評價。
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。
本次通過仿製藥一致性評價的阿莫西林顆粒主要適用於敏感菌(不產β內酰胺酶菌株)所致的成人與兒童的感染性疾病。阿莫西林顆粒備案參比製劑為安斯泰來製藥株式會社的阿莫西林細粒劑,規格為10%(1g:100mg),安斯泰來於2017年將其旗下的阿莫西林細粒劑等16個品種轉讓給LTLPharma。本次獲得《藥品補充申請批准通知書》表明安科恆益阿莫西林顆粒質量和療效與參比製劑具有一致性。
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