September 23, 2008 – In response to the FDA approval of Covidien’s ANDA for generic Kit for the Preparation of Technetium Tc99m Sestamibi Injection, Lantheus Medical Imaging said it will compete with competitive pricing.
Lantheus Medical Imaging stated that it acknowledges the FDA approval of Covidien’s ANDA for generic Kit for the Preparation of Technetium Tc99m Sestamibi Injection, and that it will continue to market Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a myocardial perfusion imaging agent, in the upcoming competitive generic marketplace with competitive pricing.
In Lantheus’ response, the company also stated that “it is not authorizing a generic version of Cardiolite,” and emphasized the history of the agent, pointing out that “Cardiolite is the only technetium-labeled myocardial perfusion agent that has been used to image more than 40 million patients, the subject of more than 10,000 publications and the imaging agent of choice within a number of seminal clinical trials, including DIAD, COURAGE, BARI-2D, ERASE, INSPIRE, IMAGING HF, STITCH and CHRISTMAS.”
For more information: www.lantheus.com and http://www.cardiolite.com/hcp/pi/pi.htm
August 17, 2023 
