Covidien granted tentative approval for generic myocardial kit

Tentative FDA approval indicates that the FDA has concluded that Covidien’s generic product is safe and effective for use as recommended in the submitted labeling. Final approval of the ANDA, which was filed by the company’s Mallinckrodt subsidiary, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, 2008. Covidien’s tentatively approved product is a generic of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.

Steve Hanley, president of Covidien, said: “With our investment in this product, we are enhancing our ability to provide a broad selection of nuclear cardiology and nuclear medicine products. This new generic kit underscores Covidien’s commitment to delivering choice and value to help customers diagnose heart disease.”