FDA approves Covidien generic Cardiolite

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The FDA has approved Covidien’s abbreviated new drug application (ANDA) for its preparation kit for Technetium Tc 99m sestamibi injection, a myocardial perfusion-imaging (MPI) agent used for detecting coronary artery disease.

With FDA approval of the ANDA, filed by the company’s Mallinckrodt subsidiary, Covidien said its generic product is now available for customers in the United States.

In response, Lantheus Medical Imaging, which currently markets the kit as Cardiolite, said that it will not authorize a generic version, adding that it “will be competitive in its pricing.”

The branded product is utilized in nearly 60 percent of the 15 million MPI studies performed in the United States annually, according to the Hamilton, Bermuda-based Covidien.

The company also said its generic product had earlier received final regulatory approval in Denmark, Germany and the United Kingdom.