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UPDATE 1-Two lots of Noven, Shire ADHD patch recalled

Mon Aug 25, 2008 9:08am EDT

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(New throughout, adds BOSTON to dateline)

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BOSTON, Aug 25 (Reuters) - Noven Pharmaceuticals Inc NOVN.O said on Monday that its marketing partner, Shire Ltd (SHP.L), is voluntarily recalling two batches of its skin patch to treat attention deficit hyperactivity disorder because of difficulties removing the release liner when the patch is peeled open.

Miami-based Noven, which developed the Daytrana patch and licenses it to drugmaker Shire, said that the recall is not due to safety concerns but due to the fact that the lots do not meet the product's release liner removal specification.

As a result, patients could have difficulties removing the liner when they peel the patch open.

"We are committed to resolving the release liner issue," said Peter Brandt, Noven's chief executive officer. "We have identified what we believe is the definite root cause and are aggressively testing potential solutions that we expect will address the issue."

The companies said that because the problem is not safety-related, all Daytrana patches, including those in the lots subject to the recall, can continue to be used unless the release liner cannot be removed or the patches are damaged while being opened.

Noven said Shire has told them that current supply levels of Daytrana are expected to be enough to ensure patients can continue to have their prescriptions filled.

(Reporting by Toni Clarke, editing by Dave Zimmerman)



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