NOVEN
PROVIDES UPDATE ON DAYTRANA® METHYLPHENIDATE
TRANSDERMAL SYSTEM |
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Shire
Undertakes Voluntary Recall of Two Lots of Daytrana® Product
Miami, FL, August 25, 2008 -- Noven Pharmaceuticals,
Inc. (NASDAQ: NOVN) today provided an update on the status of
Daytrana®, the only transdermal
patch indicated for the treatment of the symptoms of Attention
Deficit Hyperactivity Disorder (ADHD).
Daytrana®, developed
and manufactured by Noven, is licensed globally to Shire Limited.
Concurrently with this press release, Shire has announced that
it is undertaking a voluntary recall of two lots of Daytrana® product
(lots 2819811 and 2764211; NDC number 54092-553-30). Shire is
taking this action because Daytrana® patches in these lots
do not meet the product’s release liner removal specification
and, as a result, patients and caregivers could have difficulties
removing the release liner when they peel the patch open.
Shire
has advised that, because the voluntary recall is not due to
product safety issues, all Daytrana® patches, including those
in the lots subject to the recall, can continue to be used unless
the release liner cannot be removed, or the patches are damaged
while being opened. The Daytrana® prescribing information
and medication guide provide that, if a patch is damaged or the
release liner is difficult to remove, the patch should be discarded.
For additional information on this voluntary recall, see www.daytrana.com.
Peter
Brandt, Noven’s President & Chief Executive Officer,
commented: “Daytrana continues to bring important benefits
to patients with ADHD and, together with Shire, we are committed
to resolving the release liner issue. We have identified what
we believe is the definitive root cause and are aggressively
testing potential solutions that we expect will address the issue.
As previously indicated, however, until testing is completed
and solutions are implemented, voluntary actions like today’s
two lot recall are possible, as we work to assure that patients
and caregivers can use Daytrana® with the convenience they
expect from this novel ADHD treatment.”
Shire has advised
that current supply levels of Daytrana® are expected to be
sufficient to ensure that patients can continue to have their
Daytrana® prescriptions filled at their local pharmacies.
Noven continues to manufacture the product and Shire continues
to promote it in the United States
Important
Daytrana® Safety
Information
Tell your doctor about any heart conditions, including
structural abnormalities, your child or a family member may have.
Inform your doctor immediately if the child develops symptoms
that suggest heart problems, such as chest pain or fainting.
Daytrana® should not be used if the child has: significant
anxiety, tension, or agitation; allergies to methylphenidate
or other ingredients of Daytrana®; glaucoma; discontinued
in the last 14 days or is taking a monoamine oxidase inhibitor
(MAOI); tics, or family history or diagnosis of Tourette’s
syndrome.
Tell your doctor
before using Daytrana® if the
child: is being treated for or has symptoms of depression (e.g.
sadness, worthlessness, or hopelessness) or bipolar disorder;
has family history of tics; has abnormal thoughts or visions,
hears abnormal sounds, or has been diagnosed with psychosis;
has had seizures or abnormal EEGs; has or has had high blood
pressure; exhibits aggressive behavior or hostility. Tell your
doctor immediately if the child develops any of these conditions/symptoms
while using Daytrana®.
In clinical studies,
side effects were generally mild to moderate. The most common side
effects reported with Daytrana® were decreased appetite, sleeplessness,
sadness/crying, twitching, weight loss, nausea, vomiting, tics,
and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors,
mania, and growth suppression have been associated with use of
drugs of this type. Tell your doctor if the child has blurred
vision while using Daytrana®.
Note:
Abuse of Daytrana® can
lead to dependence. Daytrana® should be applied daily to
clean, dry skin, which is free of any cuts or irritation. Skin
redness or itching is common with Daytrana®. Allergic skin
rash may occur.
About Noven
Noven
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged
in the research, development, manufacture, marketing and sale of prescription
pharmaceutical products. Noven’s business and operations are
focused in three principal areas – transdermal drug delivery,
the Novogyne joint venture, and Noven Therapeutics, Noven’s
specialty pharmaceutical unit.
Safe Harbor Statement
under the Private Litigation Reform Act of 1995
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 that 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: the risk that additional lots of
Daytrana® may be recalled by Shire
due to product failing to meet the release liner specification or otherwise;
the risk that Noven may not be successful in identifying or implementing
a solution to resolve the release liner issue; uncertainties related
to the financial impact of the recall; the risk that Noven’s
response to the FDA’s January 2008 warning letter, which remains
under FDA review, may not be acceptable to the FDA or adequately 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 risk that any adverse effect
to the market for Daytrana® due to the foregoing or other factors
could adversely affect Noven’s reputation, results of operations
and/or its financial position. 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, 2007, 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.
Noven
Contact:
Joseph C. Jones
Noven Pharmaceuticals, Inc.
(305) 253-1916
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Media
Contact for Daytrana®:
Matthew Cabrey
Shire Limited
(484) 595-8248 |
Copyright © 2008 Noven
Pharmaceuticals, Inc. All rights reserved. |