Daytrana

Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System

MIAMI, December 13, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that it expects to commence the manufacture of launch supplies of Daytrana (methylphenidate transdermal system) this week.

Daytrana, licensed globally to Shire plc, is an investigational transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. An amended New Drug Application (NDA) for the product is currently pending at the U.S. Food and Drug Administration (FDA). The FDA regulatory review period under the Prescription Drug User Fee Act for Daytrana is scheduled to conclude December 28, 2005.

Earlier in December 2005, the U.S. Drug Enforcement Administration (DEA) granted Noven procurement quota (methylphenidate raw material) sufficient to manufacture launch supplies. Noven's application for additional procurement quota is currently pending at the DEA.

Source: Noven Pharmaceuticals, Inc.

Posted: December 2005

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