Covidien wins FDA approval for generic myocardial perfusion imaging kit

With FDA approval of the abbreviated new drug application (ANDA), which was filed by the company’s Mallinckrodt subsidiary, Covidien’s generic product is now available for customers in the US. The company’s generic product also has recently received final regulatory approval in Denmark, Germany and the United Kingdom.

Covidien’s generic product is pharmaceutically equivalent to Cardiolite, a myocardial perfusion imaging agent used for detecting coronary artery disease. The branded product is utilized in nearly 60% of the 15 million myocardial perfusion imaging studies performed in the US annually, the company said.

Steve Hanley, president of imaging solutions at 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.”