NOVEN
RECEIVES FDA WARNING LETTER |
BackMiami, FL, January
10, 2008 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) announced that
yesterday it received a warning letter from the U.S. Food and Drug
Administration (FDA) related to a prior on-site inspection of Noven’s
Miami manufacturing facility.
The FDA inspection concluded in early
July 2007 and, as disclosed at that time by Noven, resulted in FDA
observations on Form 483. The majority of the observations on Form
483 related to difficulties experienced by some patients in removing
the release liner of the Daytrana™ transdermal system. Noven
submitted a response to the FDA’s observations in July 2007.
In
the warning letter, the FDA cites Current Good Manufacturing Practice
deficiencies related to (i) peel force specifications for removal of
Daytrana’s release liner, and (ii) data supporting the peel force
characteristics of Daytrana’s enhanced release liner throughout
the product’s shelf life. The warning letter does not restrict
production or shipment of Daytrana™ product; it does request
additional information and analysis related to the cited deficiencies,
instructs Noven to take prompt action to address the FDA’s concerns,
and states that failure to do so may result in further regulatory action.
“Compliance
with FDA regulations is taken very seriously at Noven, and this matter
is receiving the highest priority within the company,” said Jeffrey
F. Eisenberg, Noven’s Interim Chief Executive Officer. “We
are working very closely with Shire, the global licensee of Daytrana™,
to promptly respond to the FDA’s letter, and we are committed
to working collaboratively with the FDA to fully resolve the issues.”
The
warning letter will be posted on the FDA's website at www.fda.gov and,
once posted, will be available for viewing.
About Noven
Noven Pharmaceuticals,
Inc., headquartered in Miami, Florida, has long been established as
a leading developer of advanced transdermal drug delivery technologies
and prescription transdermal products. Its commercialized transdermal
products include Vivelle-Dot® (estradiol transdermal system), the
most prescribed estrogen patch in the U.S., and Daytrana™ (methylphenidate
transdermal system), the first and only patch approved for the treatment
of ADHD. With the acquisition of JDS Pharmaceuticals in August 2007,
Noven has become a broader-based specialty pharmaceutical company with
a substantially enhanced late-stage product pipeline and the infrastructure,
products and category expertise to market and sell its own products.
See www.noven.com for additional information.
Forward Looking Information
Except
for historical information contained herein, the matters discussed in
this press release contain 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 that involve substantial risks and uncertainties.
Statements that are not historical facts, including statements which
are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or
similar expressions and statements, are forward-looking statements. Noven’s
estimated or anticipated future results, product performance or other
non-historical facts are forward-looking and reflect Noven’s current
perspective on existing trends and information. 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 that are, in many instances, beyond
Noven's control. These risks and uncertainties include, but are not limited
to, the risk that Noven’s response to the warning letter may not
be acceptable to the FDA or address the FDA’s concerns, and in
such case, the risk that the FDA may take regulatory action against Noven,
which may include fines, product seizures or recalls, injunctions, suspension
of production and/or the withdrawal of product approval; and the likelihood
that any fine or Daytrana™ product recall, injunction, seizure,
suspension of production or withdrawal of product approval would have
a material adverse effect on Noven, including the loss of Daytrana™ sales,
the potential inability to achieve the remaining Daytrana™ sales
milestone, potentially significant costs associated therewith and the
potential for litigation related to this matter. For additional information
regarding these and other risks associated with Noven’s business,
readers should refer to Noven’s Annual Report on Form 10-K for
the year ended December 31, 2006 as well as other reports filed from
time to time with the Securities and Exchange Commission. Unless required
by law, Noven undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events, or otherwise.
Contact: |
Copyright © 2008 Noven Pharmaceuticals, Inc. All rights reserved.