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FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
Date:6/27/2008

CONCERTA(R) now available for patients with ADHD ages 6 to 65

RARITAN, N.J., June 27 /PRNewswire/ -- ADHD is the most common emotional, cognitive and behavioral disorder treated in children(1), and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 percent of children with ADHD continue to exhibit symptoms in the adult years(2). ADHD is thought to affect about eight million, or one in 20, adults in the United States(3), and research on the life span of the condition notes the disorder impairs academic, social and occupational functioning(1), and is associated with academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships(1).

Today, there's a new treatment option for the millions of adults in the United States with ADHD: Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&JPRD) announced the U.S. Food and Drug Administration (FDA) approved J&JPRD's Supplemental New Drug Application (sNDA) for CONCERTA(R) treatment of ADHD in adults ages 18 to 65. The doses approved for adults range from 18 to 72 mg daily.

Today's approval expands the CONCERTA(R) indication from children and adolescents into adults with ADHD, and offers these patients a patented once- daily formulation. Using its unique OROS(R) delivery system, the CONCERTA(R) formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day.

The CONCERTA(R) brand, which was the first 12-hour extended-release methylphenidate (MPH) treatment for ADHD, is the market leader for MPH treatment of children and adolescents with ADHD. CONCERTA(R) is marketed in the United States by McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

"What we've seen in the growing body of knowledge on adult ADHD suggests a challenging burden of impairme
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SOURCE Johnson & Johnson Pharmaceutical Research & DevelopmentL.L.C.
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