Covidien Announces Tentative FDA Approval For Its Generic Myocardial Perfusion Imaging Kit

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Feb 2008 - 3:00 PDT

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Covidien (NYSE: COV, BSX: COV) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's tentatively approved product is a generic of Cardiolite®1, which is a myocardial perfusion imaging agent used for detecting coronary artery disease. The branded product is utilized in nearly 60 percent of the 15 million myocardial perfusion imaging studies performed in the U.S. annually.2

Tentative FDA approval indicates that the FDA has concluded that Covidien's generic product is safe and effective for use as recommended in the submitted labeling. Final approval of the ANDA, which was filed by the Company's Mallinckrodt Inc. subsidiary, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, 2008.

"With our investment in this product, we are enhancing our ability to provide a broad selection of nuclear cardiology and nuclear medicine products," said Steve Hanley, President of Covidien Imaging Solutions. "This new generic kit underscores Covidien's commitment to delivering choice and value to help customers diagnose heart disease."

Covidien's Imaging Solutions business is a leading provider of imaging products, including nuclear medicine solutions used by physicians to diagnose and treat various diseases. The Company is committed to offering innovative technologies to the healthcare market.

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 four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 43,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit http://www.covidien.com to learn more about our business.

References

1. Cardiolite is a registered trademark of Bristol Myers Squibb Pharma Company.
2. AMR/Arlington Medical Resources, Inc., 2006

Forward-Looking Statements

Any statements contained in this press release 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, risks and uncertainties relating to satisfaction of closing conditions related to the Retail Products business transaction, the integration of businesses we have acquired or may acquire in the future, changing technologies, product development and market acceptance of our products, the cost and pricing of our products, manufacturing, competition, customers' capital spending and government funding policies, changes in governmental regulations, the use and protection of intellectual property rights, litigation and exposure to foreign currency fluctuations. 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.

http://www.covidien.com