(NYSE: MNK) today announced that the U.S. Food and Drug Administration
(FDA) has approved the New Drug Application (NDA) for PENNSAID®
(diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical
non-steroidal anti-inflammatory drug (NSAID) approved for use in the
treatment of the pain of osteoarthritis of the knee(s).
PENNSAID 2% is supplied in an easy to use metered dose pump bottle and
is applied twice each day. PENNSAID 2% delivers an accurate amount (20
mg of diclofenac per pump actuation) and can be applied directly to the
"We have a diverse portfolio focused on pain management, and are
committed to providing options for patients who suffer from
osteoarthritis of the knee," said Mark Trudeau, Chief Executive Officer
and President, Mallinckrodt. "We are pleased that the FDA approved the
application and believe this product will be an important addition to
the Mallinckrodt Pharmaceuticals product line."
U.S. sales and marketing rights for PENNSAID 2% are licensed to
Mallinckrodt by Nuvo Research Inc.
PENNSAID® (diclofenac sodium topical
solution) 2% w/w
IMPORTANT RISK INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
WARNINGS AND PRECAUTIONS
shower for at least 30 minutes after applying PENNSAID.
wear clothing over the PENNSAID treated knee until the treated knee is
USE IN SPECIFIC POPULATIONS
Prescribing Information for additional Important Risk
Information including boxed warning.
PENNSAID is a registered trademark of Nuvo Research Inc.
Mallinckrodt is a global specialty pharmaceutical business that
develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. The company's Specialty
Pharmaceuticals segment includes branded and generic drugs and active
pharmaceutical ingredients, and the Global Medical Imaging segment
includes contrast media and nuclear imaging agents. Mallinckrodt has
approximately 5,500 employees worldwide and commercial presence in
roughly 70 countries. The company's fiscal 2013 revenue totaled $2.2
billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport
molybdenum-99 to our technetium-99m generator production facilities,
customer concentration, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
our ability to successfully develop or commercialize new products, our
ability to protect intellectual property rights, competition, our
ability to integrate acquisitions of technology, products and
businesses, product liability losses and other litigation liability, the
reimbursement practices of a small number of large public or private
issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations, information
technology infrastructure and restructuring activities. These and other
factors are identified and described in more detail in the "Risk
Factors" section of Mallinckrodt's Annual Report on Form 10-K for the
fiscal year ended September 27, 2013. We disclaim any obligation to
update these forward-looking statements other than as required by law.
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