FDA rejects King's cardiac SPECT agent
The FDA has rejected King Pharmaceuticals' new drug application (NDA) for CorVue (binodenoson), a cardiac pharmacologic stress agent for use in SPECT exams.
King, headquartered in Bristol, Tenn., said it is evaluating the FDA’s complete response letter and expects to respond to the questions as quickly as possible.
In July, the Cardiovascular and Renal Drugs Advisory Committee, which advises the FDA, voted 11 to 5 not to recommend the NDA for King's CorVue 250 mg.
King, headquartered in Bristol, Tenn., said it is evaluating the FDA’s complete response letter and expects to respond to the questions as quickly as possible.
In July, the Cardiovascular and Renal Drugs Advisory Committee, which advises the FDA, voted 11 to 5 not to recommend the NDA for King's CorVue 250 mg.