智通财经APP获悉,中国国家药监局药品审评中心(CDE)官网最新公示,赛诺菲(SNY.US)申报的盐酸非索非那定口服混悬液上市申请获得受理。公开资料显示,非索非那定是一款二代新型抗组胺药。此前非索非那定片已经在中国获批,治疗过敏性鼻炎及慢性特发性荨麻疹。本次申报上市的为口服混悬液剂型。
根据赛诺菲此前新闻稿介绍,非索非那定是二代新型抗组胺药,具有起效快、24小时长效,且不引起嗜睡,脑部受体占有率低等特点。其对H1受体的亲和力较高,表明其较好的心脏安全性。
公开资料显示,口服混悬液相比于片剂剂型,有可能帮吞咽困难的人提供更方便的治疗选择。目前,赛诺菲已经针对该产品开发了胶囊、片剂、复方制剂等多种剂型。2006年,该产品的儿童口服混悬液在美国获批上市。
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