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Early Onset Approved for ADHD Drug

30-minute onset of action for Focalin XR

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

WEDNESDAY, Nov. 12, 2008 (HealthDay News) -- The U.S. Food and Drug Administration has approved a 30-minute onset of action for Focalin XR (dexmethylphenidate HCI extended release) to treat attention-deficit hyperactivity disorder (ADHD), maker Novartis Pharmaceuticals said Wednesday.

The early onset could especially benefit children ages 6 to 12 during the morning as they get ready for school, the company said in a news release. The drug helps curtail symptoms for up to 12 hours.

ADHD affects about 3 percent to 6 percent of children in the United States, with symptoms including inattention, hyperactivity, and impulsive behavior, Novartis said.

The new labeling is based on clinical data, including a study of 86 children ages 6 to 12. The drug provided significant symptom improvement 30 minutes after administration, compared to a non-medicinal placebo, the company said.

The most common adverse reactions included abdominal pain, headache, increased appetite, and viral gastroenteritis.

More information

The FDA has more about this drug.


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