新華製藥(000756.SZ):鹽酸地爾硫䓬片(30mg)國內首家通過一致性評價
格隆匯9月21日丨新華製藥(000756.SZ)宣佈,公司全資子公司高密公司於近日收到國家藥品監督管理局核准簽發的鹽酸地爾硫䓬片(30mg)《藥品補充申請批准通知書》,該產品通過仿製藥質量和療效一致性評價。高密公司成為國內鹽酸地爾硫䓬片(30mg)首家通過仿製藥一致性評價的企業。截至目前,公司用於鹽酸地爾硫䓬片的一致性評價已投入研發費用約為1007萬元(未經審計)。
鹽酸地爾硫䓬片是國家醫保目錄乙類藥,為處方藥品。地爾硫䓬為苯並噻氮䓬類鈣離子通道阻滯劑,是第三代抗心絞痛藥和第四代抗心律失常藥,主要用於冠心病,心絞痛,以及輕、中度高血壓,對伴有冠心病,心絞痛的高血壓患者尤為適用。
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