Covidien Announces Tentative FDA Approval For Its Generic Myocardial Perfusion Imaging Kit

Covidien (NYSE: COV, BSX: COV) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company’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®1, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.

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Filed under: Cardiovascular on March 3rd, 2008