人福醫藥(600079.SH):鹽酸拉貝洛爾片獲得美國FDA批准文號
格隆匯10月9日丨人福醫藥(600079.SH)宣佈,近日,公司全資子公司Epic Pharma收到美國食品藥品監督管理局(FDA)關於鹽酸拉貝洛爾片的批准文號。藥品名稱為Labetalol Hydrochloride Tablets USP(鹽酸拉貝洛爾片);申請事項為ANDA(美國新藥簡略申請,即美國仿製藥申請。ANDA獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品。)
鹽酸拉貝洛爾片適用於各種類型高血壓。Epic Pharma於2019年提交鹽酸拉貝洛爾片的ANDA申請,累計研發投入約為110萬美元。根據IQVIA數據統計,2019年該藥品在美國市場的總銷售額約為5000萬美元,主要生產廠商包括PAR FORM、TEVA等。
根據米內網數據統計,2019年度鹽酸拉貝洛爾所有劑型在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為5000萬元人民幣,主要生產廠商包括江蘇迪賽諾製藥有限公司、海南靈康製藥有限公司、鄭州凱利藥業有限公司等。
此次鹽酸拉貝洛爾片獲得美國FDA批准文號標誌着Epic Pharma具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響,公司後續將積極推進該產品在美國市場的上市準備工作。
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