智通财经APP讯，山东新华制药股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的苯巴比妥片《药品补充申请批准通知书》，该产品通过仿制药质量和疗效一致性评价。
2025年5月，新华制药向国家药品监督管理局药品审评中心(CDE)递交苯巴比妥片一致性评价申报资料并获受理，2026年5月获得《药品补充申请批准通知书》，审评结论为：经审查，本品通过仿制药质量和疗效一致性评价。
本品主要用于治疗焦虑、失眠(用于睡眠时间短早醒患者)、癫痫，是治疗癫痫大发作及部分性发作的药物。本品属于《国家基本药物目录》与《国家基本医疗保险、工伤保险和生育保险药品目录(2025年)》甲类品种。根据相关统计数据，2025年中国公立医疗机构苯巴比妥销售额约为人民币2.2亿元。
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