COOK IMAGING OXILAN SIMILAR TO IOHEXOL IN VISUALIZATION RATINGS AND AE PROFILE; NON-IONIC CARDIAC X-RAY CONTRAST AGENT FIRST NDA APPROVAL FOR FIRM
Executive Summary
Cook Imaging Corp.'s Oxilan demonstrates visualization ratings and an adverse event profile similar to iohexol (Sanofi Winthrop's Omnipaque). The non-ionic, low osmolar, tri-iodinated X-ray contrast agent was approved Dec. 21. Oxilan was designated "1S", denoting a standard review by FDA of a new molecular entity.