April 10, 2006

The FDA has approved Daytrana, the first once-daily transdermal patch to treat attention-deficit/hyperactivity disorder (ADHD) in children.

Shire Pharmaceuticals, which licenses the drug from Noven Pharmaceuticals, said it plans to launch the product in mid-2006. Daytrana (methylphenidate) was approved April 6 for the treatment of ADHD in children ages 6-12. The product will be available in 10-, 15-, 20- and 30-mg dosage strengths, with a dosing period of nine hours. The FDA issued the firms an approvable letter for the product in March.

Adverse events observed for Daytrana in clinical trials were consistent with the known effects of methylphenidate, which is the active ingredient in other common ADHD drugs. Adverse events included decreased appetite, insomnia, nausea, vomiting, weight loss, tics and mood swings.