FDA tentatively approves Covidien?s myocardial perfusion imaging agent
The FDA has granted tentative approval for Covidien’s abbreviated new drug application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection.
The tentatively approved product is a generic of Cardiolite, a myocardial perfusion imaging agent used for detecting coronary artery disease manufactured by Bristol-Myers Squibb, according to the St. Louis-based Covidien.
The branded Cardiolite is utilized in nearly 60 percent of the 15 million myocardial perfusion imaging studies performed in the U.S. annually, according to research by Arlington Medical Resources, a Philadelphia-based pharmaceutical market research firm.
Final approval of the ANDA, which was filed by Covidien’s subsidiary Mallinckrodt, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, the company said.
The tentatively approved product is a generic of Cardiolite, a myocardial perfusion imaging agent used for detecting coronary artery disease manufactured by Bristol-Myers Squibb, according to the St. Louis-based Covidien.
The branded Cardiolite is utilized in nearly 60 percent of the 15 million myocardial perfusion imaging studies performed in the U.S. annually, according to research by Arlington Medical Resources, a Philadelphia-based pharmaceutical market research firm.
Final approval of the ANDA, which was filed by Covidien’s subsidiary Mallinckrodt, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, the company said.