华北制药(600812.SH):阿莫西林胶囊及盐酸二甲双胍片通过仿制药一致性评价
格隆汇1月15日丨华北制药(600812.SH)公布,近日,公司收到国家药品监督管理局核准签发的阿莫西林胶囊(0.5g、0.25g)和盐酸二甲双胍片(0.5g)的《药品补充申请批件》,上述药品通过仿制药质量和疗效一致性评价。
阿莫西林属于青霉素类广谱β-内酰胺类抗生素,对大多数致病的革兰氏阳性菌及革兰氏阴性菌均有强大的抑菌和杀菌作用,临床广泛用于治疗敏感菌所致上呼吸道感染、泌尿生殖道感染、皮肤软组织感染、下呼吸道感染以及与其他药物联用根除幽门螺杆菌,且轻中度肾病患者无需调整剂量。开展一致性评价工作以来,该药品两个规格累计研发投入1038.76万元人民币(未经审计)。
盐酸二甲双胍片首选用于单纯饮食控制及体育锻炼控制血糖无效的2型糖尿病。对于成人,可用于单药治疗,也可以与磺脲类药物或胰岛素联合治疗。对于10岁及以上的儿童和青少年,可用于单药治疗或与胰岛素联合治疗。本品由Merck研发,1957年在法国上市,商品名为Glucophage;1995年03月03日获美国FDA批准在美国上市。开展一致性评价工作以来,该药品研发投入约828万元人民币(未经审计)。
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