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CENTOCOR MYOSCINT UPTAKE RELATIONSHIP TO INCIDENCE OF CARDIAC EVENTS SUGGESTED BY SPONSOR, QUESTIONED BY FDA COMMITTEE; TISSUE IMAGES SUBJECT OF DEBATE

Executive Summary

Centocor's assertion that extensive Myoscint uptake may be an indicator for a higher incidence of subsequent cardiac events was received skeptically by FDA's Cardiovascular & Renal Drugs Advisory Committee at its Jan. 26 meeting. The committee voted to recommend approval for the monoclonal antibody-based cardiac imaging agent imciromab pentetate but did not accept the agent's ability to determine degree of necrosis ("The Pink Sheet" Jan. 29, T&G-1).
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