Covidien Granted Tentative FDA Approval for Generic Myocardial Perfusion

The FDA granted tentative approval for Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien’s tentatively approved product is a generic 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, according to the company.
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 is subject to the expiration of the marketing exclusivity period for the branded product July 29, 2008.