智通财经APP讯，上海医药(02607)公布，近日，公司下属浙江信谊瑞爵制药有限公司(以下简称“信谊瑞爵”) 收到美国食品药品监督管理局(以下简称“美国 FDA”)的通知，其关于糠酸莫米松鼻喷雾剂的简略新药申请(“ANDA”，即美国仿制药申请)已获得批准(“Approval”)。
糠酸莫米松鼻喷雾剂主要用于预防/治疗青少年和成人的季节性鼻炎，以及治疗成人伴有鼻息肉的慢性鼻窦炎。糠酸莫米松鼻喷雾剂最早由默克集团的先灵葆雅公司研发并于 1997 年在美国上市。2018 年 3 月，信谊瑞爵就该药品向美国 FDA 提出 ANDA 申请，并于近日获得批准文号。自上海医药立项时起至本公告日，信谊瑞爵针对该药品已投入研发费用约人民币 4,944.89 万元。
本次信谊瑞爵关于糠酸莫米松鼻喷雾剂的 ANDA 获得美国 FDA 批准，对公司进一步拓展海外市场具有积极意义。
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