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FDA approves label change for ADHD medication


PHILADELPHIA The Food and Drug Administration has approved a labeling change for an attention deficit hyperactivity disorder drug to reflect new efficacy data.

British drug maker Shire announced that the FDA had approved the change for the drug Vyvanse CII (lisdexamfetamine dimesylate) to include clinical data showing that the drug can control ADHD symptoms in children aged 6 to 12 for 13 hours after they take it. Shire said Vyvanse is the first oral ADHD drug to have such data included in its product labeling.

“Children with ADHD who still exhibit symptoms into the evening might need a treatment that provides a long duration of effect from morning, through homework and family time,” Shire ADHD business unit SVP Michael Yasick said in a statement. “The FDA approval of this labeling change for Vyvanse provides important additional information for physicians on the duration of effect of Vyvanse and use as a once-daily treatment option.”

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