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2013年11月,FDA批出1个新生物制品和4个新分子实体药品(表1),分别是治疗白血病药品Gazyva(奥妥珠单抗)、治疗癫痫病药品Aptiom(醋酸艾司利卡西平)、治疗罕见淋巴瘤药品Imbruvica(依布鲁替尼)、抗真菌药物Luzu(卢立康唑)以及丙肝新药Olysio(司美匹韦)。1 Gazyva(奥妥珠单抗)Gazyva获“优先审评”和“孤儿药”地位,FDA批准其与苯丁酸氮芥联用治疗既往未治疗过的慢性淋巴性白血病(CLL)患者。Gazyva是首个糖基化的II型
In November 2013, the FDA awarded 1 new biological product and 4 new molecular entity drugs (Table 1) for the treatment of leukemia drug Gazyva (opalizumab), epilepsy drug Aptiom (esmolol acetate Xiping), Imbruvica (Ibrutinib) for the treatment of rare lymphomas, Luzu (Lolidoconazole) as an antifungal agent and Olysio (Cimetidine), a new hepatitis C drug. 1 Gazyva Gazyva Receives “Priority Review” and “Orphan Drugs” Status FDA Approves Its Use with Chlorambucil for Previously untreated Chronic Lymphoblastic Leukemia (CLL )patient. Gazyva is the first glycosylated type II