ADHD patch receives FDA "approvable letter"

NEWS IN BRIEF — Posted Jan. 23, 2006

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A skin patch that provides medication to treat attention-deficit/hyperactivity disorder in children ages six to 12 may be approved by the Food and Drug Administration, according to a statement issued last month by Noven Pharmaceuticals and Shire PLC, the companies developing the product.

The FDA issued an "approvable letter" for methylphenidate transdermal system (Daytrana), recommending label revisions and post-marketing surveillance as necessary to gain the agency's approval.

"Noven and Shire will be working with the FDA as necessary to address the remaining issues and to advance the [new drug application] toward final approval," said Noven President and CEO Robert C. Strauss.

Previous applications for approval had been declined because of problems with insomnia and anorexia associated with wearing the patch for 12 hours. Fewer adverse events have been associated with shorter wearing times, and one of the agency's advisory panels recommended last month that the label encourage its use primarily by children who had problems taking the medication's pill form.

Note: This item originally appeared at

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