Covidien gets tentative FDA approval

Medical products maker Covidien Ltd. said today that federal regulators granted tentative marketing approval for its generic version of Bristol-Myers Squibb Co.'s Cardiolite, an imaging agent used in cardiac stress tests.

Covidien's product, the Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, helps clinicians see how well blood is flowing through the heart.

Tentative FDA approval means the FDA found Covidien's generic product to be safe and effective for use as recommended in the submitted labeling. Final approval can be granted once Cardiolite's marketing exclusivity period expires on July 29.

Shares of Bermuda-based Covidien fell 24 cents to $43.55 in morning trade. (AP)