FDA Issues Approvable Letter for Daytrana(TM) Methylphenidate Transdermal System

In its letter, the FDA states that it has completed its review ofthe amended New Drug Application (NDA) for Daytrana(TM) and hasdetermined that it is approvable. The approvable letter containsproposed revisions to labeling, as well as requests for dataclarification, post marketing surveillance, and post-marketingstudies.

"We are pleased that the FDA has determined that Daytrana(TM) isapprovable for the treatment of ADHD," said Robert C. Strauss, Noven'sPresident, CEO & Chairman. "Noven and Shire will be working with theFDA as necessary to address the remaining issues and to advance theNDA toward final approval."

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

Daytrana(TM) is a trademark of Shire.

Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is aleading developer of advanced transdermal drug delivery technologiesand prescription transdermal products. Noven's prescription patchesare sold in over 30 countries, and a range of new products are beingdeveloped in collaboration with Shire plc, Novartis Pharma AG, P&GPharmaceuticals, Endo Pharmaceuticals Inc. and others. Seehttp://www.noven.com for additional information.

Except for historical information contained herein, the mattersdiscussed in this press release contain forward-looking statementswithin the meaning of Section 27A of the Securities Act of 1933 andSection 21E of the Securities Exchange Act of 1934 that involvesubstantial risks and uncertainties. Actual results, performance orachievements could differ materially from those contemplated,expressed or implied by the forward-looking statements containedherein. These forward-looking statements are based largely on thecurrent expectations of Noven and are subject to a number of risks anduncertainties that are subject to change based on factors which are,in many instances, beyond Noven's control. These risks anduncertainties include: the risk that the product may not ultimately beapproved; risks related to final product labeling, including the riskthat warnings or limitations required by the FDA may adversely affectthe commercial success of the product; risks related to post-marketingsurveillance and studies; the risk of supply interruptions and otheruncertainties relating to future DEA awards of methylphenidateprocurement quota necessary for the production of Daytrana(TM); therisk that Noven may encounter production issues and/or inefficienciesin the process of manufacturing commercial quantities of Daytrana(TM),which could adversely affect the success of product launch and Noven'sresults of operations; and risks related to competition (includingfrom other ADHD products marketed by Shire) and market acceptance ofthe product that could adversely affect the commercial success ofDaytrana(TM) and could, among other things, limit Noven's right toreceive the additional milestone payments under its agreement withShire. For additional information regarding these and other risksassociated with this product and Noven's business, readers shouldrefer to Noven's Annual Report on Form 10-K for the year endedDecember 31, 2004 as well as other reports filed from time to timewith the Securities and Exchange Commission.