华润医药(03320.HK)旗下润生药业哮喘仿制药申请获美国FDA受理并进入实质审查
华润医药(03320.HK)公布,旗下子公司华润三九联合华润医药产业投资基金共同参股的润生药业,向美国FDA递交的Advair Diskus仿制药ANDA申请,FDA已经受理并进入实质审查。作为同类药品不超过3家的品种,FDA给予了该申请优先审评资格。
作为润生药业首个核心产品,沙美特罗替卡松粉吸入剂为对GSK的Advair Diskus高端仿制药。该药用於治疗4岁及以上患者的哮喘以及气流阻塞的维持治疗和减少慢性阻塞性肺病患者的急性发作。
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