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Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System

MIAMI, December 23, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter relating to Daytrana (methylphenidate transdermal system), a developmental product under FDA review for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. Daytrana is licensed globally to Shire plc.

In its letter, the FDA states that it has completed its review of the amended New Drug Application (NDA) for Daytrana and has determined that it is approvable. The approvable letter contains proposed revisions to labeling, as well as requests for data clarification, post marketing surveillance, and post-marketing studies.

"We are pleased that the FDA has determined that Daytrana is approvable for the treatment of ADHD," said Robert C. Strauss, Noven's President, CEO & Chairman. "Noven and Shire will be working with the FDA as necessary to address the remaining issues and to advance the NDA toward final approval."

If the product is ultimately approved, Noven will receive a $50 million milestone payment from Shire, and may earn additional milestone payments of up to $75 million depending on the level of Shire's commercial sales of the product. In addition, Noven expects to earn a profit on the manufacture and supply of finished product to Shire.

Daytrana is a trademark of Shire.

Source: Noven Pharmaceuticals, Inc.

Posted: December 2005

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