Executive Summary

The US FDA has told Epix Pharmaceuticals that it will delay until September the completion of a review of the firm's appeal regarding its magnetic resonance imaging (MRI) vascular contrast agent, Vasovist. The appeal concerns two previously-issued FDA approvable letters for the product, one of which requested that at least one additional trial be performed before the product could be sanctioned. It was lodge by the Cambridge, Massachusetts firm on June 30 2006, and asks that the agency approve Vasovist and use an advisory committee as part of the appeal process (see Clinica No 1213, p 19).