Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expand And Constrict

 
• By Michael Cipriano and Bridget Silverman
  
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The latest drug development news and highlights from our US FDA Performance Tracker. 

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It was a time for celebration at the US FDA, which approved the first generic alternative to Mylan NV's EpiPen (epinephrine) two years after the company became a poster child for high drug prices. Although much of the criticism had been directed at Mylan for its pricing practices, FDA became a punching bag as well with criticism of its generic drug approval process.

Genentech Inc. picked up a broad breakthrough therapy designation for its anti-IgE antibody Xolair (omalizumab) for the prevention of...

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