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FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
Date:5/4/2010

PHILADELPHIA, May 4 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, 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 now the first and only oral ADHD long-acting stimulant treatment to have efficacy data at 14 hours postdose for adult patients included in its product labeling.

"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," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "Shire is pleased with the FDA approval of this labeling change for Vyvanse."

The update to the Vyvanse product lab
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SOURCE Shire plc
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