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Shire withdraws some ADHD skin patches

WASHINGTON
Tue Sep 4, 2007 12:00pm EDT

WASHINGTON (Reuters) - British drugmaker Shire Plc has withdrawn some of its attention deficit hyperactivity disorder skin patches because users have had difficulty removing the liners covering the patches, the company said on Tuesday.

Health  |  Regulatory News

Britain's No. 3 drugmaker said 3 percent to 5 percent of children or their caregivers had trouble removing the liners. The liners must be peeled off before the patches, called Daytrana, are affixed to the skin.

The problem is not related to safety or efficacy issues, the company said. Daytrana patches contain methylphenidate, a central nervous system stimulant.

The U.S. Food and Drug Administration supports the company's withdrawal. Shire said.

The company has sold an estimated 700,000 patches since approval in 2006, a spokesman said, based on prescription data. It began selling an easier-to-remove liner in March 2007 but said it could not estimate how many patches on the market are the older version.

Shire spokesman Matthew Cabrey said the withdrawal should cost the company less than $10 million.

The product is licensed to Shire from Noven Pharmaceuticals.



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