NOVEN
SUBMITS RESPONSE TO ALZA CITIZEN PETITION ON FENTANYL PATCH
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Miami, FL, December
27, 2004 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced
that it has submitted comments to the U.S. Food & Drug Administration
(FDA) in response to a pending citizen petition intended to prevent
or delay the approval of certain generic versions of Johnson & Johnson’s
Duragesic® product (fentanyl transdermal system).
Noven’s comments address the issues raised in the citizen
petition submitted by Alza Corporation (an affiliate of Johnson & Johnson)
in November 2004, and otherwise offer insight into the characteristics
of adhesive matrix transdermal patches. A copy of Noven’s
comments, and a link to the subject citizen petition, are available
on Noven’s website at www.noven.com/cpresponse1.htm.
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.
Investor & Media
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2004 Noven
Pharmaceuticals, Inc. All rights reserved. |