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以嶺藥業(002603.SZ):帕羅西汀片獲得美國FDA批准文號
格隆匯 11-09 17:06

格隆匯11月9日丨以嶺藥業(002603.SZ)公佈,近日,公司收到美國食品品監督管理局(以下簡稱美國FDA)的通知,公司全資子公司以嶺萬洲國際制藥有限公司向美國FDA申報的ANDA產品帕羅西汀片(ANDA,即美國仿製藥申請,申請獲得美國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)已獲得批准。

帕羅西汀片為選擇性中樞神經 5-羥色胺再攝取抑制劑,可使突觸間隙中 5-羥色胺濃度增高,發揮抗抑鬱作用。對其他遞質作用較弱,對植物神經系統和心血管系統的影響較小。本品適應症抑鬱症亦可治療強迫症、驚恐障礙社交焦慮障礙

帕羅西汀片最早由GlaxoSmithKline 研發,於1992 12 月在美國獲批上市。當前,美國市場帕羅西汀片的主要供貨商為APOTEX TECHNOLOGIES INC TEVA PHARMACEUTICAZYDUS PHARMACEUTICALS USA INC 等六家。近三年帕羅西汀片在美國市場銷售額為:2018 年約0.47億美元,2019 年約0.42億美元,2020 年約0.33億美元(數據來源於IMS數據庫)。

截至目前,公司在帕羅西汀片研發項目上已投入研發費用1000萬元人民幣。

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