FDA Approves VYVANSE CII Label Change To Include Supplementary Clinical Data Supporting Efficacy At 13 Hours Postdose In Children Age 6-12 With ADHD

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE® (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.

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Filed under: ADHD on June 4th, 2009