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FDA Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder in Children

By Pharmaceutical Processing | April 17, 2006

The FDA recently approved Daytrana, the first transdermal (skin) patch, for treating Attention Deficit Hyperactivity Disorder (ADHD) in children six to 12 years of age. Daytrana is a once daily treatment containing the drug methylphenidate, a central nervous system (CNS) stimulant.

“Daytrana provides an alternative route of administration for methylphenidate in children with ADHD, ” said Dr. Galson, FDA’s, Director of the Center for  Drug Evaluation and Research.

Daytrana has been shown to be safe and effective in two placebo controlled studies in children six to 12 years of age with ADHD. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures such as psychological, education and social, for patients with ADHD. Daytrana is manufactured for Shire US. Inc., by Noven Pharmaceuticals Inc.

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