FDA
DENIES CITIZEN PETITIONS ATTEMPTING TO DELAY
APPROVAL OF GENERIC FENTANYL PATCHES
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Miami, FL, January
28, 2005 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced that
the U.S. Food & Drug Administration (FDA) today denied pending
citizen petitions intended to prevent or delay the approval of certain
generic versions of Johnson & Johnson’s Duragesic® product
(fentanyl transdermal system). FDA denied the petitions of ALZA Corporation;
Drs. Brookoff and Voth; London & Mead; and Dr. Steven L. Shafer.
Noven’s fentanyl patch is a transdermal delivery system for the
management of chronic pain. An Abbreviated New Drug Application for
Noven’s patch is pending at the FDA. Marketing rights to the
product in the U.S. and Canada have been licensed to Endo Pharmaceuticals
Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc.
(NASDAQ: ENDP).
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a
leading developer of advanced transdermal drug delivery technologies
and prescription transdermal products. Noven’s prescription patches
are approved in over 30 countries, and a range of new patches are being
developed in collaboration with Novartis Pharma AG, Shire Pharmaceuticals
Group plc, Procter & Gamble Pharmaceuticals, Endo Pharmaceuticals
Inc. and others. Together with Novartis Pharmaceuticals Corporation,
Noven owns Novogyne Pharmaceuticals, a profitable women’s health
products company with 2003 sales of over $100 million. Among other
products, Novogyne markets and sells Noven’s Vivelle Dot® product
– the smallest estrogen patch in the world, and the most dispensed
transdermal estrogen product in the U.S. Noven is committed to expanding
the universe of available transdermal therapies for the benefit of
patients, partners and shareholders. See www.noven.com for additional
information.
This press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933
and Section
21E of the Securities Exchange Act of 1934. Actual results, performance
or achievements could differ materially from those contemplated,
expressed or implied by the forward-looking statements contained
herein. These forward-looking statements are based largely on the
current expectations of Noven and are subject to a number of risks
and uncertainties that are subject to change based on factors which
are, in many instances, beyond Noven’s control. Reference
is made to the risks and factors detailed in Noven’s Annual
Report on Form 10-K as well as other reports filed by Noven with
the Securities and Exchange Commission.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2005 Noven
Pharmaceuticals, Inc. All rights reserved. |