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绿叶制药:美国FDA要求提供更多信息才批准LY03004新药上市申请
阿思达克 01-31 12:25

绿叶制药(02186.HK)公布,公司收到美国食品药品监督管理局(FDA)就公司每两周注射一次的缓释微球肌肉注射制剂,用於治疗精神分裂症及双相情感障碍一型的产品LY03004的新药上市申请(NDA)发出的完整回覆函,要求提供更多的信息并解决原料药生产场地的检查问题後才能批准此新药上市申请。

公司将与原料药合作夥伴和美国FDA密切沟通来解决完整回覆函中提到的所有问题,并迅速的推进这个NDA的批准流程。公司董事对尽快地推进LY03004的FDA上市批准流程有信心。

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