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Covidien Supports FDA on Acetaminophen Safe Use

^{Published on 2011-01-13 06:56:27 - Market Wire}
 

ST. LOUIS--([ BUSINESS WIRE ])--Covidien (NYSE: COV), a leading global provider of healthcare products and the worlda™s largest producer of acetaminophen, supports the U.S. Food and Drug Administration (FDA) on the safe use of acetaminophen.

This morning, the FDA requested manufacturers to voluntarily limit the acetaminophen content of each prescription pill or capsule to no more than 325 mg within three years. In addition, the agency announced new labeling requirements for prescription products containing acetaminophen.

Covidien is the only North American manufacturer of acetaminophen. The Company also manufactures prescription products that combine acetaminophen with the pain medications hydrocodone and oxycodone, all of which are already available in 325 mg formulations.

Based on its current understanding of the FDA action, Covidien does not anticipate a material impact to its fiscal 2011 Pharmaceuticals sales, operating income or Company operating margin.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has approximately 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit [ www.covidien.com ] to learn more about our business.

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. 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 effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payors and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.