悦康藥業(688658.SH):注射用頭孢他啶通過仿製藥一致性評價
格隆匯1月6日丨悦康藥業(688658.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的關於注射用頭孢他啶(1.0g)的《藥品補充申請批准通知書》(通知書編號:2021B04912),該藥品通過仿製藥質量和療效一致性評價。
頭孢他啶為強效、廣譜的第三代頭孢菌素類抗生素,較第一、二代頭孢菌素對革蘭氏陰性菌活性與β-內酰胺酶穩定性增強,與其他第三代頭孢菌素相比,對銅綠假單胞菌作用最強,常作為敏感菌的首選用藥之一。注射用頭孢他啶適用於敏感革蘭陰性桿菌所致的敗血症、下呼吸道感染、腹腔和膽道感染、複雜性尿路感染和嚴重皮膚軟組織感染等。
注射用頭孢他啶為2020版國家醫保乙類品種及2018年版國家基藥目錄品種。根據米內網數據顯示,2020年在國內城市公立醫院、城市社區醫院、縣級公立醫院及鄉鎮衞生院終端銷售總額約為53.92億元。
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