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普洛藥業(000739.SZ):鹽酸安非他酮緩釋片(XL)獲得美國FDA PAS批准
格隆匯 01-13 16:34

格隆匯1月13日丨普洛藥業(000739.SZ)公佈,近日,普洛藥業股份有限公司全資子公司浙江巨泰藥業有限公司收到了美國食品藥品監督管理局(簡稱“美國FDA”)簽發的鹽酸安非他酮緩釋片(XL)新增藥品生產場地PAS(Prior Approval Supplement)的批准通知。

鹽酸安非他酮緩釋片(XL)用於治療抑鬱症。該藥物由VALEANT INTERNATIONAL BARBADOS SRL研發,於2003年8月28日在美國上市。根據相關數據顯示,鹽酸安非他酮口服劑型2023年在美國市場銷售額約為7.6億美元。

鹽酸安非他酮緩釋片(XL)(規格:300mg)ANDA(簡略新藥申請)已於2019年獲得美國FDA批准;鹽酸安非他酮緩釋片(XL)(規格:150mg)sANDA(簡略新藥補充申請)已於2020年獲得美國FDA批准。

截至公吿披露日,鹽酸安非他酮緩釋片累計投入的研發費用為人民幣2,094.8萬元。

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