FDA Approves Methylphenidate HCl Extended-Release Tablets for Treatment of ADHD in Adults
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FDA Approves Methylphenidate HCl Extended-Release Tablets for Treatment of ADHD in Adults

RARITAN, NJ -- June 27, 2008 -- The US Food and Drug Administration (FDA) has approved methylphenidate HCl extended-release tablets (Concerta) for treatment of attention deficit hyperactivity disorder (ADHD) in adults aged 18 to 65 years. The doses approved for adults range from 18 to 72 mg daily.

Today's FDA approval was based on clinical trial data in adults aged 18 to 65 years. In these studies, use of methylphenidate HCl extended-release tablets was shown to significantly improve ADHD symptoms such as attention, impulsivity, and hyperactivity compared with placebo. In addition, the medication was generally well tolerated.

This expands the drug indication from children and adolescents into adults with ADHD.

SOURCE: Johnson & Johnson

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