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标题: FDA批准Teva Phamaceuticals批准生产Truvada的通用版本 [打印本页]

作者: StephenW    时间: 2017-6-10 16:08     标题: FDA批准Teva Phamaceuticals批准生产Truvada的通用版本

www.natap.org


Please see the statement below. Thanks.
  
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FDA has granted Teva Phamaceuticals approval to produce a generic version of Truvada. It’s important to note that there are number of factors involved in commercialization that are not tied directly to FDA approval.

A generic version of Truvada will not be immediately available.  The patent for tenofovir disoproxil fumarate (TDF), a component of Truvada, expires July 2017 and has pediatric exclusivity until January 2018.  The patent for emtricitabine, a component of Truvada, expires in 2021.
  
Gilead believes Truvada for PrEP is an important HIV prevention tool and we remain committed to helping ensure access to our medications for people both at risk of or living with HIV.

www.natap.org


  请参阅下面的声明。 谢谢。
  
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  FDA批准Teva Phamaceuticals批准生产Truvada的通用版本。 重要的是要注意,商业化的因素有很多,不直接与FDA批准相关。

  Truvada的通用版本将不会立即提供。 Truvada组成部分的替诺福韦地索他芬富马酸(TDF)的专利将于2017年7月到期,直到2018年才具有儿科排他性。特鲁华达组成的恩曲他滨的专利将于2021年到期。
  
  Gilead认为Truvada为PrEP是一个重要的艾滋病毒预防工具,我们仍然致力于帮助确保艾滋病毒风险或艾滋病毒感染者接触我们的药物。
  





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