Gensia Inc. has submitted applications to regulatory authoritiesin both the U.S. and Europe for approval to market its GenESAsystem for diagnosing coronary artery disease.
Gensia (NASDAQ:GNSA) submitted a new drug application to theFDA and marketing authorization applications to the EuropeanCommunity's Committee for Proprietary Medicinal Products(CPMP) on Tuesday.
The GenESA system combines the drug arbutamine and acomputer-controlled drug administration system designed topharmacologically stress the heart to aid in the diagnosis ofcoronary artery disease. Gensia of San Diego has developedGenESA to be used with the three major modalities for testingfor coronary artery disease: electrocardiography,echocardiography and radionuclide imaging.
Gensia said it also intends to seek regulatory approval of thesystem in Canada and from the members of the European FreeTrade Association in the first quarter of 1994. -- Jennifer VanBrunt
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