上海醫藥(02607.HK):抗心絞痛藥鹽酸胺碘酮片通過仿製藥一致性評價
格隆匯3月1日丨上海醫藥(02607.HK)發佈公吿,近日,公司全資子公司上海上藥信誼藥廠有限公司收到國家藥監局頒發的關於鹽酸胺碘酮片的《藥品補充申請批准通知書》(通知書編號:2022B00704),該藥品通過仿製藥一致性評價。
根據披露,鹽酸胺碘酮片主要用於抗心絞痛藥,用於房性、結性、室性和伴W-P-W綜合徵的心律失常,由WYETHPHARMS研發,於1985年在美國上市。2020年10月,上藥信誼就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至該公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣696.58萬元。
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