Covidien 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(R)(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.
Steve Hanley, President, Imaging Solutions, Covidien said, With the launch of our generic product, we are broadening the selection of nuclear cardiology solutions in our product portfolio. 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.