眾生藥業(002317.SZ):氫溴酸右美沙芬片通過仿製藥質量和療效一致性評價
格隆匯1月8日丨眾生藥業(002317.SZ)公佈,近日,公司全資子公司廣東華南藥業集團有限公司(以下簡稱“華南藥業”)收到國家藥品監督管理局批准簽發的《藥品補充申請批件》,批件號:2019B04697。據查詢國家藥品監督管理局藥品審評中心網站了解,國內目前尚未有其他企業申報申請氫溴酸右美沙分類藥物的仿製藥質量和療效一致性評價,華南藥業為目前國內氫溴酸右美沙芬片按照仿製藥質量和療效一致性評價政策補充申請申報唯一一家通過的企業。
氫溴酸右美沙芬片為鎮咳類非處方藥藥品,屬於甲類非處方藥,適用於乾咳,包括上呼吸道感染(如感冒和咽炎),支氣管炎等引起的咳嗽。氫溴酸右美沙芬為中樞性鎮咳藥,可抑制延腦咳嗽中樞而產生鎮咳作用,其鎮咳作用與可待因相等或稍強。一般治療劑量不抑制呼吸,長期服用無成癮性和耐受性。1956年被美國食品藥品監督管理局(FDA)列為非處方藥,且被FDA譽為“現代最安全”的中樞鎮咳藥;1961年在世界麻醉藥會議上被定為非麻醉藥;1989年,世界衞生組織認為“右美沙芬是取代可待因的一種鎮咳藥”。用藥人羣從兒童到老人,範圍廣泛。
右美沙芬是2019年醫保目錄中4種不含複方祛痰藥的鎮咳藥中的一種,米內網中國城市公立醫院化學藥終端競爭格局數據庫顯示,右美沙芬2018年銷售額在入選2019年醫保目錄不含複方祛痰藥的鎮咳藥中排名第一。
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