Berlex Ultravist imaging agent will be launched in July; approved May 10, two years after advisory committee.
Executive Summary
BERLEX ULTRAVIST CONTRAST AGENT WILL BE AVAILABLE IN JULY, the company announced May 12. The iodinated, non-ionic contrast agent iopromide for x-ray imaging and computed tomography scanning (NDA 20-220) was approved by FDA on May 10, almost two years after FDA's Medical Imaging Drugs Advisory Committee unanimously recommended approval for eight indications ("The Pink Sheet" May 31, 1993, T&G-2).