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Covidien Receives FDA Approval for South African-Produced Medical Isotope Based on Low-Enriched Uranium

Fri, 03/11/2011 - 4:34pm
Covidien

ST. LOUIS, Mar 10, 2011 (BUSINESS WIRE) --

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved the use of molybdenum-99 (Mo-99) derived from low-enriched uranium (LEU) in the production of technetium-99m (Tc-99m) generators. Tc-99m is a medical isotope, utilized in over 80% of all nuclear medicine studies, supplied to hospitals and nuclear pharmacies by Covidien's Mallinckrodt business.

Tc-99m is produced when Mo-99 decays following uranium irradiation. The approval by the FDA allows use of LEU-based Mo-99 supplied by South Africa's NTP Radioisotopes, Ltd., a subsidiary of the Nuclear Energy Corporation of South Africa, in Tc-99m generator production at Covidien's Maryland Heights, MO, manufacturing facility.

Tc-99m is a critical medical isotope used in diagnostic and functional studies of organs and anatomical systems. The information from these studies is used by many medical specialists (including radiologists, cardiologists, nephrologists and oncologists) to better diagnose and treat patients. More than 30 million nuclear medicine procedures are performed worldwide each year using Tc-99m, more than half in the United States.

"This FDA approval represents another step in our commitment to move toward LEU conversion in the production of Mo-99 and Tc-99m," said Elaine Haynes, Vice President and General Manager, Imaging, Americas.

In January, 2009, the Company launched a collaborative effort with Babcock & Wilcox Technical Services Group (B&W) to develop solution-based reactor technology for LEU-based medical isotope production, a unique approach designed to provide an efficient domestic supply source. The project combines Covidien's expertise in radiopharmaceutical production and global regulatory approvals with B&W's patented liquid phase nuclear technology. Covidien is also developing plans for conversion of its Mo-99 processing facility in Petten, the Netherlands, to facilitate use of LEU.

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 and the Foreign Corrupt Practices Act, 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 and environmental remediation costs. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the fiscal year ended September 24, 2010, and in subsequent filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

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