康哲藥業(00867.HK):Neurelis產品VALTOCO鼻腔噴霧劑(NRL-1)獲美國FDA上市批准
格隆匯1月13日丨康哲藥業(00867.HK)發佈公告,Neurelis於2020年1月13日宣佈,美國FDA已批准其產品VALTOCO(地西泮鼻腔噴霧劑)作為一種急性治療藥物,用於治療六歲及以上癲癇患者的間歇性、刻板性癲癇頻繁發作活動(即癲癇叢集性發作、急性反覆性癲癇發作),這種發作不同於患者通常的癲癇發作模式。
該集團已於Neurelis向美國FDA遞交新藥申請後,在中國積極開展VALTOCO的註冊申請等相關工作,並於近期獲得了中國國家藥品監督管理局對地西泮鼻噴霧劑的臨牀試驗通知書,要求該集團開展針對中國人羣的比較藥代動力學研究,並在本品申請註冊上市的同時提交上市後進一步驗證本品療效及安全性的臨牀研究計劃。
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