潤都股份(002923.SZ):鹽酸左布比卡因注射液通過一致性評價
格隆匯3月29日丨潤都股份(002923.SZ)公佈,近日,公司收到國家藥監局郵寄的《藥品補充申請批准通知書》,公司藥品“鹽酸左布比卡因注射液(10ml:50mg)”通過仿製藥質量和療效一致性評價,並同意增加鹽酸左布比卡因注射液(10ml:75mg)規格的補充申請。
該藥品“鹽酸左布比卡因注射液”的臨牀適應症為:主要用於外科硬膜外阻滯麻醉。
公司表示,鹽酸左布比卡因注射液通過仿製藥質量和療效一致性評價,有利於提高市場競爭力,併為公司後續產品開展仿製藥質量和療效一致性評價工作積累寶貴經驗。
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