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Article: FDA Issues Complete Response Letter for CorVue™.
- Article from:
- Heart Disease Weekly
- Article date:
- November 8, 2009
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King Pharmaceuticals, Inc. (NYSE: KG) announced 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 (see also King Pharmaceuticals, Inc.).
King is currently evaluating the FDA's complete response letter and expects to respond to the Agency's questions as quickly as ...