Centocor's Myoscint adequate in detecting suspected MI, clinical utility unclear -- FDA advisory committee.
Executive Summary
CENTOCOR MYOSCINT PERFORMANCE STANDARD ADEQUATE, CLINICAL UTILITY QUESTIONABLE for the detection of myocardial infarction, FDA's Cardiovascular & Renal Drugs Advisory Committee, with representation from the Medical Imaging Drugs Advisory Committee, concluded Jan. 26. The committee voted 8-5 to recommend Myoscint's approval (PLA 95-1210) for imaging in the setting of chest pain suspected to be caused by myocardial infarction.
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