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Shire Gets FDA Approval For Vyvanse Label Change

Shire, a global biopharmaceutical company, has received FDA approval for a change to the prescribing information for its once-daily attention deficit hyperactivity disorder (ADHD) treatment Vyvanse (lisdexamfetamine dimesylate) Capsules CII.

The change is to include supplemental data demonstrating significant improvement in attention in adults with ADHD across all six assessments conducted at two, four, eight, 10, 12 and 14 hours after administration as measured by average permanent product measure of performance (PERMP) total scores, as well as at each time point measured.

Vyvanse is the oral ADHD long-acting stimulant treatment to have efficacy data at 14 hours postdose for adult patients included in its product labeling.

Michael Yasick, senior vice president of the ADHD business unit at Shire, said: “The availability of an ADHD treatment for adults that provides efficacy throughout the day and into the evening is important as adults may need to manage their symptoms beyond the work day. Shire is pleased with the FDA approval of this labeling change for Vyvanse.”