FDA Approves Concerta (Methylphenidate) 27 mg Extended Release for Attention Deficit/Hyperactivity Disorder

FORT WASHINGTON, PA — April 2, 2002 — The U.S. Food and Drug Administration (FDA) has approved Concerta® (methylphenidate HCl) 27 mg Extended-release Tablets, offering greater dosing flexibility for the treatment of attention deficit/hyperactivity disorder (ADHD).

Concerta is also available in 18 mg, 36 mg, and 54 mg strengths.

Concerta can be initiated and dosed safely and effectively, even in patients who have never taken ADHD medication. "It is recommended that Concerta therapy be initiated with 18 mg taken once daily in the morning and titrated up to 36 mg if no improvement in symptoms is seen," said Patrick Ciccone, MD, vice president, Medical, McNeil Consumer & Specialty Pharmaceuticals. "The Concerta 27 mg tablet provides ADHD patients an interim dose between the 18 and 36 mg tablets for a more gradual titration."

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