Drug maker King Pharmaceuticals Inc. (KG) reported Wednesday that the U.S. Food and Drug Administration issued a complete response letter regarding the New Drug Application,or NDA, for its cardiac imaging injection CorVue.
The company had developed CorVue for use in patients with coronary artery disease or CAD, who are unable to perform a cardiac exercise stress test. The injection is intended to be an adjunct to non-invasive myocardial imaging tests to detect perfusion abnormalities in patients.
The company noted that it is currently evaluating the complete response letter and expects to respond to the Agency's questions as quickly as possible.
The Bristol, Tennessee- based company had submitted the NDA for CorVue on December 18, 2008 based on results from two late-stage trials. Earlier this year, an advisory panel to the FDA voted 11-5 against the approval on ineffectiveness of the formulation.
CAD, one of the most common forms of cardiovascular disease, affecting 16 million adults and killing more than 450,000 people annually, about one out of every five deaths in the U.S.
KG is currently trading $10.82, down 1.50% on a volume of 1.46 million shares on the NYSE.
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