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Mylan Confident On Advair Generic First-Round Approval

Executive Summary

President Rajiv Malik said there has been “huge movement” at the agency around executing on the first ANDA for a generic version of GlaxoSmithKline’s blockbuster Advair.

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Advair: A Big Generic Opportunity And A Big Question Mark In 2017

Takeda’s Velcade, Pfizer’s Viagra and Gilead’s Viread are among the brand drugs expected to face generic competition in the US for the first time in 2017. One unknown is if FDA will approve Mylan’s or Hikma’s ANDAs for a generic version of GSK’s Advair.

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