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Mallinckrodt Pharmaceuticals New Drug Application Approved by the FDAST. LOUIS --(Business Wire)-- Mallinckrodt (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 affected knee(s). "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 Cardiovascular Risk
Gastrointestinal Risk
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
shower for at least 30 minutes after applying PENNSAID. wear clothing over the PENNSAID treated knee until the treated knee is dry
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
See Full Prescribing Information for additional Important Risk Information including boxed warning. PENNSAID is a registered trademark of Nuvo Research Inc. ABOUT MALLINCKRODT: 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. FORWARD-LOOKING STATEMENTS 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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