The Hamilton, Bermuda-based company said that it launched the product after the U.S. Food and Drug Administration (FDA) approved its abbreviated new drug application. The branded version of Cardiolite is marketed by Lantheus Medical Imaging of North Billerica, MA, and is used in nearly 60% of the 15 million myocardial perfusion studies performed annually in the U.S., according to Covidien.
Covidien said that its generic version of Cardiolite has recently received final regulatory approval in Denmark, Germany, and the U.K.
In a statement, Lantheus said it will continue to market its branded version of Cardiolite and will not market its own generic version of the agent. The company is highlighting Cardiolite's track record in imaging 40 million patients over 17 years, as well as its support and service for the branded product.
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