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King Pharmaceuticals receives FDA complete response letter for CorVue NDA

21. October 2009 07:55

King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection. CorVue™ is a cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.

King is currently evaluating the FDA’s complete response letter and expects to respond to the Agency’s questions as quickly as possible.

SOURCE King Pharmaceuticals, Inc.

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Posted in: Medical Condition News | Pharmaceutical News

Tags: Adenosine, Blood Vessel, Cardiovascular Disease, Coronary Artery Disease, Dyspnea, Exercise, Hospital, Neuroscience, New Drug Application, Stress

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