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Shire Pharmaceutical's patch for ADHD recommended to FDA

Date published: 05/12/2005

Shire Pharmaceuticals has announced that the Psychopharmacologic Drugs Advisory Committee has recommended that the US Food and Drug Administration (FDA) approve its Daytrana (methylphenidate transdermal system) for the treatment of attention deficit hyperactivity disorder (ADHD). Daytrana is designed for once-daily use to treat ADHD in children aged six to 12 years.

The FDA asked the advisory committee to vote on whether the product has been shown to be effective for the treatment of ADHD, and whether the product has been shown to be acceptably safe in the treatment of ADHD. On the first question, the committee voted unanimously in favor of the efficacy of the product. On the second question, the committee voted unanimously in favor of the safety of the product, but recommended that the FDA require post-marketing surveillance and/or studies related to the product.

"We are pleased that the Advisory Committee voted in favor of Daytrana's safety and efficacy in children diagnosed with ADHD," said Shire chief executive officer Matt Emmens.

"This delivery option can provide a much needed alternative for parents and physicians to help children living with ADHD."

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