Generic Tc 99m Sestamibi Cardiac Radiotracer Cleared

 

October 31, 2008

The FDA granted approval for Covidien’s generic kit for the preparation of technetium Tc99m Sestamibi injection use for nuclear myocardial perfusion imaging.

Covidien’s product is a generic version of Cardiolite, 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.