人福醫藥(600079.SH):鹽酸多西環素片獲得美國FDA批准文號
格隆匯 12 月 17日丨人福醫藥(600079.SH)公佈,近日,公司全資子公司Epic Pharma, LLC (“Epic Pharma”)收到美國食品藥品監督管理局(FDA)關於鹽酸多西環素片的批准文號,現將主要情況公告如下:
藥品名稱:Doxycycline Hyclate Tablets USP(鹽酸多西環素片)
申請事項: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。)
鹽酸多西環素片可用於治療立克次體病,如流行性斑疹傷寒、地方性斑疹傷寒、洛磯山熱、恙蟲病和Q熱;支原體屬感染;衣原體屬感染,包括鸚鵡熱、性病、淋巴肉牙腫、非特異性尿道炎、輸卵管炎、宮頸炎及沙眼;迴歸熱;布魯菌病等症狀。Epic Pharma於2020年提交鹽酸多西環素片的ANDA申請,累計研發投入約為100萬美元。根據IQVIA數據統計,2019年該藥品在美國市場的總銷售額約為2000萬美元,主要生產廠商包括Lupin Phama、Mayne Phama等。根據米內網數據統計,2019年度多西環素全劑型在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為2億元人民幣,主要生產廠商包括永信藥品工業(崑山)股份有限公司、海口奇力製藥股份有限公司、富祥(大連)製藥有限公司等。
此次鹽酸多西環素片獲得美國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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