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FDA接受Teva和Medincell的UZEDY用于治疗双相I型障碍的补充申请
UZEDY目前在美国获准每一个月或两个月使用一次,作为成年人精神分裂症治疗的皮下长效注射剂(LAI)。此次补充新药申请是基于UZEDY现有的临床数据,以及FDA此前对已获批用于治疗BP-I的利培酮制剂的安全性和有效性的研究结果。
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