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興齊眼藥(300573.SZ):伏立康唑滴眼液獲得臨牀試驗通知書
格隆匯 09-15 16:50

格隆匯 9 月 15日丨興齊眼藥(300573.SZ)公佈,公司的新藥伏立康唑滴眼液於今日獲得國家藥品監督管理局簽發的藥物臨牀試驗批准通知書(通知書編號:2020LP00460),上述新藥的臨牀試驗申請已於2020年6月16日獲得國家藥品監督管理局的受理。

藥品名稱:伏立康唑滴眼液;受理號:CXHL2000294;劑型:滴眼劑;申請事項:國產藥品註冊;註冊分類:化學藥品2.2類;申請人:瀋陽興齊眼藥股份有限公司;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年6月16日受理的伏立康唑滴眼液符合藥品註冊的有關要求,同意開展真菌性角膜炎的臨牀試驗。

伏立康唑(voriconazole)是美國輝瑞公司研究開發的一種新型三唑類廣譜抗真菌藥,具有抗菌譜廣,抗菌效力強等特點,其作用機制是通過競爭性抑制真菌羊毛甾醇14α-去甲基化酶,使細胞膜重要組成成分麥角甾醇的生物合成受阻而發揮抗真菌作用。目前,國內外已上市銷售的伏立康唑製劑有注射劑、片劑、膠囊劑和幹混懸劑,尚未有伏立康唑眼用製劑上市。

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