人福醫藥(600079.SH):乙琥胺軟膠囊獲美國FDA批准文號
格隆匯3月17日丨人福醫藥(600079.SH)公佈,近日,公司控股子公司PuraCap Pharmaceutical LLC(以下簡稱“美國普克”,公司持有其72%的股權)收到美國食品藥品監督管理局(FDA)關於乙琥胺軟膠囊的批准文號。
乙琥胺軟膠囊主要用於控制癲癇小發作。美國普克於2017年提交乙琥胺軟膠囊的ANDA申請,累計研發投入約為70萬美元。根據IQVIA數據統計,最近12個月乙琥胺軟膠囊在美國市場的總銷售額約為870萬美元,主要生產廠商包括Strides Pharma、Bionpharma、Akorn和Heritage Pharms等。根據國家藥品監督管理局網站顯示,目前國內沒有乙琥胺製劑獲批上市銷售。
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