京新藥業(002020.SZ):獲得首個美國ANDA批准文號
格隆匯 6 月 29日丨京新藥業(002020.SZ)公佈,近日,浙江京新藥業股份有限公司(以下簡稱“公司”)收到美國食品和藥品監督管理局(以下簡稱“FDA”)的通知,公司受讓美國VintagePharmaceuticals,LLC((以下簡稱“美國Vintage公司”)所持有的左乙拉西坦片的簡略新藥申請(以下簡稱“ANDA”)的所有權變更已獲得美國FDA的確認。
一、藥品基本情況
1、藥品名稱:左乙拉西坦片
2、ANDA申請號:091491
3、劑型:口服片劑
4、規格:250mg、500mg、750mg、1000mg
5、申請事項:所有權變更申請
6、申請人:浙江京新藥業股份有限公司
二、藥品的其他相關情況
左乙拉西坦是比利時UCB公司開發研製的一種新型抗癲癇藥物,用於成人及4歲以上兒童癲癇患者部分性發作的加用治療。公司通過資產購買方式取得了美國Vintage公司的左乙拉西坦片(ANDA申請號:091491)。截止公告日,本次ANDA文號的轉移工作已完成,公司成為該品種(左乙拉西坦片;ANDA申請號:091491)的持有人。
三、對公司的影響
左乙拉西坦片為公司首個引入的ANDA品種,標誌着公司具備了在美國市場銷售該產品的資格,將對公司做強精神神經產品、拓展美國製劑市場、提升公司業績帶來積極的影響。由於該產品在國外市場銷售的時間、市場規模、後續拓展進度具有不確定性,且容易受到國外市場環境變化、匯率波動等因素影響,敬請廣大投資者謹慎決策,注意防範投資風險。
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