金陵药业(000919.SZ)分公司收到药品上市申请不予批准通知

智通财经04-15

智通财经APP讯，金陵药业(000919.SZ)公告，公司分公司金陵药业股份有限公司南京金陵制药厂(简称“金陵制药厂”)于近日收到国家药品监督管理局下发的《药品上市申请不予批准通知书》，相关药品名称为：碳酸司维拉姆干混悬剂。

该药品主要用于控制正在接受透析治疗的慢性肾脏病(CKD)成人患者的高磷血症等的治疗。本次不予批准的原因为：现有资料不能支持该药品体外生物等效性结论。

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