FDA approves J&J's application for adult ADHD medication

RARITAN, N.J. The Food and Drug Administration has approved Johnson & Johnson’s application for Concerta for the treatment of attention deficit hyperactivity disorder in adults ages 18 to 65. The doses approved range from 18 mg to 72 mg. McNeil Pediatrics markets Concerta in the United States.

“What we’ve seen in the growing body of knowledge on adult ADHD suggests a challenging burden of impairment in everyday functioning,” said Janet Vergis, president of McNeil Pediatrics. “Recognizing this need—and as the market leader in extended-release methylphenidate for children and adolescents—we see today’s approval as a treatment option milestone for adults with ADHD and their healthcare professionals. We are proud to offer patients ages 6 to 65 with ADHD our Concerta product knowledge based on more than seven years of clinical experience.”

According to the FDA, Concerta had sales of over $1 billion in 2007.