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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

nt in everyday functioning," said Janet Vergis, President of McNeil Pediatrics(TM). "Recognizing this need -- and as the market leader in extended-release MPH 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(R) product knowledge based on more than seven years of clinical experience."

Researchers examining ADHD across the lifespan have noted the condition is often chronic, with prominent symptoms and impairment spanning into adulthood, and is often associated with co-occurring anxiety, mood and disruptive disorders as well as substance abuse(3). According to the NIMH, ADHD is thought to be a biological condition, usually inherited, and tends to run in some families more than others. Often when a child is diagnosed with the disorder, a parent will recognize that he or she had many of the same symptoms, and for the first time, will begin to understand some of the traits that have troubled them for years(4). All aspects of an individual's life must be considered in the diagnosis and treatment of ADHD(3).

Today's FDA approval was based on clinical trial data in adults ages 18 to 65. In these studies, use of CONCERTA(R) was shown to significantly improve ADHD symptoms such as attention, impulsivity and hyperactivity compared to placebo, and the medication was shown to be generally well tolerated.

About CONCERTA(R)

CONCERTA(R) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

CONCERTA(R) should not be taken by patients who have: allergies to methylph
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SOURCE Johnson & Johnson Pharmaceutical Research & DevelopmentL.L.C.
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