Covidien wins FDA OK for generic heart image agent

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Healthcare products company Covidien announced the US Food and Drug Administration granted tentative approval for its generic imaging agent used for detecting coronary artery disease.


The product is a generic of Cardiolite, an injected substance that shows blood flow inside the heart during exercise and rest. Cardiolite, often used in stress tests, was manufactured by the unit of Bristol-Myers Squibb Co that was sold last month to Avista Capital Partners.

Covidien said the branded product is utilized in nearly 60 per cent of the 15 million myocardial perfusion imaging studies performed in the United States each year.

(Reporting by Debra Sherman, editing by Gerald E. McCormick)

Tags: Covidien - wins - FDA - OK - for - generic - heart - image - agent
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