Label Change Approved for Vyvanse

Once-daily drug now may cover symptoms for up to 13 hours.

Biopharmaceutical company Shire has received FDA approval to change the prescribing information for its once-daily attention deficit hyperactivity disorder (ADHD) treatment Vyvanse, for up to 13 hours.

Studies on the medication in children ages 6 to 12 have shown symptom control from 1.5 hours (the first time point measured) through 13 hours postdose. The most frequently reported adverse events were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and mood swings.

Vyvanse has been approved for the treatment of ADHD in children aged 6 to 12 years and adults. It is currently available in six dosage strengths.

Read more about the new labeling.