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U.S. FDA and Health Canada Approve Use of Molybdenum 99 From Maria Reactor
Approvals Will Help Ease Critical Shortage
ST. LOUIS, Mar 11, 2010 (BUSINESS WIRE) -- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.

Tc 99m is a vital medical isotope used in over 80 percent of all nuclear medicine diagnostic and functional studies of organs and anatomical systems. The information from these studies is used by many medical specialists (including radiologists, nephrologists, oncologists and cardiologists) to better diagnose and treat patients. More than 35 million nuclear medicine procedures are performed worldwide each year, more than half in the United States.

On February 17, 2010, in Warsaw, Poland, Covidien and the Institute of Atomic Energy in Poland (IAE POLATOM) announced an agreement for Maria to begin supplying Mo 99. At the time, it was estimated that the Mo 99 supplied from Maria would help meet the needs of more than one million additional patients worldwide in just the first six months.

"We are pleased that both FDA and Health Canada expedited their reviews of our data, resulting in a quick approval," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "Their actions are great news for patients who may have been facing longer delays in receiving critical nuclear medicine diagnostic procedures."

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 2009 revenue of $10.7 billion, Covidien has 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 and www.covidien.com/Mo99supply to learn more about Mo 99 supply.

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, the possibility that the Maria Research Reactor may not be able to supply Mo 99 in a volume or form sufficient to meet our needs or at all, 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 payers 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, including legacy Tyco-related litigation, 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.

SOURCE: Covidien

Covidien
John Gillespie, 314-654-3263
Manager, Media Relations
john.gillespie@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President, Public Relations
bruce.farmer@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Brian Nameth, 508-452-4363
Director, Investor Relations
brian.nameth@covidien.com

Stock Quote

COV (Common Stock)
ExchangeNYSE
(US Dollar)
Price$69.86
Change (%) Stock is Up 0.02
 (0.03%)
Volume1,996,576
As of 04/17/14 4:07 p.m. ET
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