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In Brief: Gensia Sicor

This article was originally published in The Gray Sheet

Executive Summary

Gensia Sicor: Receives approvable letter from FDA for its GenESA arbutamine drug infusion system for the additional indication of use with echocardiography in the diagnosis of coronary artery disease in patients who cannot exercise adequately. The notice follows an earlier approvable letter for a new drug application for use of the system in diagnosis of coronary artery disease with radionuclide myocardial perfusion imaging ("The Gray Sheet" May 26, I&W-7). Clearance of both indications is contingent upon FDA's approval of final labeling. GenESA, slated for launch during the third quarter, will be marketed by the 25-person sales force of Gensia's Automedics subsidiary at a price of $15,000...
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