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CorVue FDA Approval Status

FDA Approved: No
Brand name: CorVue
Generic name: binodenoson
Company: King Pharmaceuticals, Inc.
Treatment for: Diagnosis and Investigation

CorVue (binodenoson) is an investigational cardiac pharmacologic stress SPECT (single-photon-emission computed tomographic) imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.

In October 2009, King Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for CorVue (binodenoson) had not been approved.

Development timeline for CorVue

Oct 21, 2009FDA Issues Complete Response Letter for CorVue
Dec 19, 2008King Pharmaceuticals Announces Submission of New Drug Application for CorVue

Further information

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