Berlex' Ultravist Approved In USA; Launch In July?

Schering AG subsidiary Berlex Laboratories has been granted marketing clearance for Ultravist (iopromide), an injectable, iodinated nonionic contrast agent for X-ray imaging and computed tomography scanning, by the US Food and Drug Administration. The company expects to launch the product in the USA in July.

Ultravist, which is described as a second-generation imaging agent, is indicated for a broad range of diagnostic procedures including: cerebral and peripheral arteriography and left venticulography; excretory urography; aortography and visceral angiography; intra-arterial digital subtraction angiography; peripheral venography; and contrast-enhanced CT scanning of the head and body.

The approval was based on clinical trials involving more than 700 patients in which Ultravist demonstrated "effective visualization of normal and abnormal vascularity and anatomy with a safety profile comparable to other marketed nonionic agents," according to Berlex. Ultravist will complement Berlex' other marketed imaging agents, which include Magnevist (gadopentetate dimeglumine) for magnetic resonance imaging, and will be manufactured in Germany.