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Methylphenidate Transdermal System Deemed Not Approvable by FDA

Miami, FL, April 28, 2003 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) has received notification from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for its methylphenidate transdermal system is not approvable. A "not approvable" letter is issued if the FDA believes that the application contains insufficient information for an approval action at the time of issuance. The product is licensed to Shire Pharmaceuticals Group plc.

"We are disappointed with the Agency's determination, and continue to believe that our product represents a valuable new therapy for the management of Attention Deficit Hyperactivity Disorder," said Robert Strauss, Noven's President, CEO & Chairman. "In its letter, the FDA cited clinical and other issues as the basis for non-approval. We are developing our strategy for approval, and plan to meet with the Agency as soon as possible to clarify their concerns and to determine what additional studies, analysis or other actions would resolve the issues raised in the letter."

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