Covidien Announces FDA Approval For Its Generic Myocardial Perfusion Imaging Kit

Main Category: MRI / PET / Ultrasound
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 24 Sep 2008 - 9:00 PDT

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Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's generic product is pharmaceutically equivalent to Cardiolite®1, 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

With FDA approval of the ANDA, which was filed by the Company's Mallinckrodt subsidiary, Covidien's generic product is now available for customers in the United States. The Company's generic product also has recently received final regulatory approval in Denmark, Germany and the United Kingdom.

"With the launch of our generic product, we are broadening the selection of nuclear cardiology solutions in our product portfolio," said Steve Hanley, President, Imaging Solutions, Covidien. "This new generic kit is a demonstration of Covidien's ongoing investment and commitment to provide valuable diagnostic imaging agents to the nuclear medicine community."

Covidien's Imaging Solutions business is a leading provider of radiopharmaceuticals used in nuclear medicine imaging procedures. It also supplies contrast media delivery systems, which combine contrast media and power injectors, for Computed Tomography (CT), X-ray and Magnetic Resonance Imaging (MRI) 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 four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 42,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit http://www.covidien.comto learn more about our business.

1. Cardiolite is a trademark of Lantheus Medical Imaging, Inc.

2. AMR/Arlington Medical Resources, Inc., 2006

Covidien

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