FDA Questions King's CorVue In Complete Response Letter

摘要

King Pharmaceuticals has received a complete response letter from the FDA for its NDA for CorVue, a cardiac-imaging adjunct drug.rnCorVue (binodenoson) is an injectable drug designed for use as an adjunct in single-photon-emission CT cardiac imaging. The procedure is used in patients who have or are at risk for coronary artery disease and who can't undergo an exercise stress test. CorVue is designed to minimize side effects of the procedure such as flushing, difficulty breathing, chest pain and heart block.