FDA Must Decide How To Handle Subgroups In Labeling For Boceprevir, Telaprevir
Executive Summary
In what is poised to be one of the biggest marketing battles of the year, as Merck's Victrelis (boceprevir) and Vertex's Incivek (telaprevir) close in upon approval, how FDA handles different subgroups of hepatitis C patients in labeling for each of the protease inhibitors could be a determining factor.
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