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FDA Approves 30-Minute Onset Label for ADHD Med
Stimulant medication may be useful for controlling children's symptoms in the mornings
Friday November 14th - 10:26am
The FDA has approved a new labeling, 30-minute onset of action, for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD), bringing potential benefits for children and their families during the morning period when they are preparing for school.
The new labeling is based on clinical data from a study from Baylor College of Medicine. In the study of 86 children with ADHD between the ages of six and 12, Focalin XR (from Novartis Phamaceuticals) provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment, and academic productivity.
The extended-release medication also helps patients manage symptoms for up to 12 hours. The most common side events were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.
Read more about the medication.
What do you think of this article? Share your comments on www.ADDConnect.com, ADDitude's community site. Check out the new ADHD Medication User Reviews and the ADHD Adults Support Group. Your fellow ADDers want to hear from you!