2月12日,Mylan宣布在美国正式上市Wixela Inhub(氟替卡松/沙美特罗)。Wixela Inhub是GSK明星重磅品种Advair Diskus的首个仿制药,在1月30日获批每日2次用于治疗4岁以上哮喘患者以及慢性阻塞性肺病(COPD)患者的气管阻塞。 葛兰素史克Advair全球销售额(百万英镑) Mylan同时公布了3个不同规格Wixela的批发商采购价格(who...
申请类型 ANDA 申请号 208891 药品名称 WIXELA INHUB 活性成分 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 活性成分中文 暂无权限 执行时间 2019-02-06 持有公司 MYLAN 说明书 下载 VIP试用医疗器械查询APP下载客服中心常见问题数据可视化数据分析挖掘系统网站地图业务介绍友情链接 400-678-0778 投诉...
Wixela Inhub and Advair Diskus are comparable in terms of functionality, user interface, and device resistance. The primary objectives of the studies were to evaluate in vitro dose delivery with Wixela Inhub compared with Advair Diskus at relevant flow rates and to explore inhalation profiles ...
The in vitro performance of Wixela Inhub is comparable to that of Advair Diskus at all dosage strengths (100/50μg, 250/50μg, and 500/50μg) and all flow rates. Wixela Inhub has pharmacokinetic and pulmonary therapeutic bioequivalence to Advair Diskus, which has well-established efficacy,...
Subjects diagnosed with asthma or COPD were provided Inhub inhaler training and subsequently self-administered 3 weeks of twice daily doses of Wixela Inhub 250 mu g FP/50 mu g salmeterol in the home environment. The Inhub inhalers were returned to the investigator after similar to 3 weeks ...
2月12日, Mylan 宣布在美国正式上市Wixela Inhub(氟替卡松/沙美特罗),这是GSK重磅品种舒利迭的首个仿制药,用于治疗4岁以上哮喘患者以及慢性阻塞性肺病(COPD)患者的气管阻塞。首仿药价直降70%,降的太厉害, 恒瑞 的还在研发路上,看来是没戏了。
This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation. Methods: This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in ...