8-K

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (date of earliest event reported): April 25, 2003

Noven Pharmaceuticals, Inc.
11960 S.W. 144th Street, Miami, Florida 33186

305-253-5099

Incorporated under the laws of the	Commission File Number	I.R.S. Employer Identification Number
State of Delaware	0-17254	59-2767632

TABLE OF CONTENTS

EX-99.1 PRESS RELEASE

Item 5. Other Events.

     On April 25, 2003, Noven Pharmaceuticals, Inc. 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.

     A copy of Noven’s press release announcing the FDA action is filed as Exhibit 99.1 and incorporated herein by this reference.

Item 7. Exhibits

     (c)  Exhibits.

99.1 Press release dated April 28, 2003 announcing the receipt of a “not approvable” letter from the FDA.

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SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	NOVEN PHARMACEUTICALS, INC.
	/s/ Jeffrey F. Eisenberg Jeffrey F. Eisenberg Vice President, General Counsel and Corporate Secretary
Date: April 29, 2003

INDEX TO EXHIBITS

Exhibit No.	Description
99.1	Press Release, dated April 28, 2003, announcing the receipt of a “not approvable” letter from the FDA

EX-99.1 3 g82413exv99w1.htm EX-99.1 PRESS RELEASE

EXHIBIT 99.1

NOVEN RECEIVES “NOT APPROVABLE” LETTER FROM FDA
FOR METHYLPHENIDATE TRANSDERMAL SYSTEM

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.”

Noven will address the FDA letter on its earnings conference call, scheduled for Wednesday, April 30, at 11:00 a.m. The call will be broadcast live via the Internet at http://www.noven.com, and a rebroadcast will be accessible at the same site. A taped replay of the call will be available by telephone beginning April 30 at noon through May 2 at noon by calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from outside the U.S.) and entering the conference ID# 64158 and the access code 1628.

Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. For additional information on Noven, visit www.noven.com.

This release contains forward-looking information related to the business of Noven that can be identified by the use of forward-looking terminology such as “believe,” “plan,” and similar words and phrases. Such statements are qualified by and subject to the risks and uncertainties specified in Noven’s most recent filings with the Securities and Exchange Commission and those specified herein, including the risk that Noven may not receive regulatory approvals for MethyPatch, particularly in the United States after the receipt of a “not approvable” letter from the FDA, and that additional clinical studies may be required.

Contact:
Joseph C. Jones
Vice President — Corporate Affairs
(305) 253-1916

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EX-99.1

EX-99.1 PRESS RELEASE