永太科技(002326.SZ):鹽酸多西環素膠囊的ANDA獲得美國FDA批准
格隆匯4月1日丨永太科技(002326.SZ)公佈,近日,公司全資子公司浙江永太藥業有限公司(“永太藥業”)收到美國食品藥品監督管理局(“FDA”)的通知,永太藥業向美國FDA申報的鹽酸多西環素膠囊簡略新藥申請(ANDA,即美國仿製藥申請)獲得批准。
鹽酸多西環素膠囊,用於治療立克次體感染、性病、呼吸道感染、特定細菌感染、眼科感染、炭疽,對青黴素過敏者某些特定感染的替代治療,輔助治療急性腸道阿米巴病和嚴重痤瘡,並可用於預防瘧疾。
鹽酸多西環素膠囊原研廠為輝瑞製藥公司,國外生產、銷售廠商主要有輝瑞製藥公司、梯瓦製藥美國公司及邁蘭製藥公司等。經查詢IMS數據庫,鹽酸多西環素膠囊2017年7月至2018年6月全球銷售額約為5.40億美元,其中美國市場銷售額約為3.91億美元;2018年7月至2019年6月全球銷售額約為4.01億美元,其中美國市場銷售額約為2.60億美元。
此次鹽酸多西環素膠囊的ANDA獲得美國FDA的批准,標誌着公司具備了在美國市場銷售該產品的資格,標誌着公司在仿製藥產品領域業務的進一步推進,對公司拓展美國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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