FDAnews
www.fdanews.com/articles/82681-epix-pharmaceuticals-gets-approvable-letter-for-vasovist

EPIX PHARMACEUTICALS GETS APPROVABLE LETTER FOR VASOVIST

November 23, 2005

Epix Pharmaceuticals has reported that the FDA has provided the company with an "approvable" letter related to the novel blood-pool contrast agent, Vasovist. This is the second approvable letter received by the company from the FDA since a new drug application for Vasovist was filed in December 2003.

Vasovist is a gadolinium-based magnetic resonance imaging blood pool contrast agent optimized for prolonged vascular enhancement. After intravenous injection, Vasovist binds reversibly to human serum albumin in plasma, thus providing higher relaxivity (contrast enhancement) and an extended imaging time window over currently available contrast agents.