INTRAVASCULAR IOTROLAN IN THE US - WORK-IN-PROGRESS

The ongoing clinical development of iotrolan 280 mgI/ml for intravascular indications in the United States includes computed tomography, excretory urography, cerebral arteriography, aortography/visceral angiography, and peripheral arteriography. The safety, efficacy and patient tolerance of iotrolan has been assessed in two phase I and ten phase II and III multicenter, randomized, double-blind trials involving over 500 patients and volunteers. Each indication has been studied in two double-blind trials. It is anticipated that once these trials are complete, the data will permit a New Drug Application to be submitted to the US Food Drug Administration.