September 23, 2008 – The FDA has 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.
With FDA approval of Covidien’s abbreviated new drug application (ANDA), the generic product is now available for customers in the U.S. The company’s generic product also has recently received final regulatory approval in Denmark, Germany and the U.K.
The marketing exclusivity period for Lantheus Medical Imaging’s Cardiolite ended on July 29. The new generic product will challenge the name brand, which has been an industry standard and marketed in the U.S. for the past 17 years.
Lantheus said it will continue to market Cardiolite in the upcoming competitive generic marketplace and will stand by its existing distribution network, customer service and radiopharmaceutical manufacturing processes. Lantheus said it also plans to be competitive in its pricing.
The company said Cardiolite has been used to image more
than 40 million patients and has been the subject of more than 10,000 publications. The company said it was also the imaging agent choice in a number of seminal clinical trials, including DIAD, COURAGE, BARI-2D, ERASE, INSPIRE, IMAGING HF, STITCH and CHRISTMAS.