天士力(600535.SH):子公司鹽酸二甲雙胍片通過仿製藥一致性評價
格隆匯1月26日丨天士力(600535.SH)公佈,近日,公司全資子公司江蘇天士力帝益藥業有限公司(以下簡稱“江蘇帝益”)收到國家藥品監督管理局頒發的關於鹽酸二甲雙胍片0.25g規格的《藥品補充申請批准通知書》,該藥品通過仿製藥一致性評價。
鹽酸二甲雙胍片首選用於單純飲食及體育鍛煉控制血糖無效的2型糖尿病,為國家基本藥物,並進入國家醫保目錄(甲類)。該藥品於2019年10月10日向國家藥監局遞交一致性評價申請,於2019年10月18日獲得受理。截至本公吿日,江蘇帝益針對該藥品一致性評價已投入研發費用約為458.82萬元人民幣。
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