FDA approves Novartis’ Focalin for treatment of ADHD

EAST HANOVER, N.J. The Food and Drug Administration has approved a 30-minute onset of action for Novartis’ Focalin XR extended-release capsules for treating attention deficit hyperactivity disorder.

Novartis said the approval would bring potential benefits for young patients and their families during the morning period when they are preparing for school.

“The morning is a critical time for families,” Baylor College of Medicine associate professor of psychiatry Alice Mao said in a statement. “The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine.”

Clinical studies, including a recent one, have shown that the drug, known generically as dexmethylphenidate hydrochloride, provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment and academic productivity.