LEXINGTON, Mass.--(BUSINESS WIRE)--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has submitted a formal appeal to Steven Galson, M.D., director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the CDER director to approve the company’s novel blood-pool imaging agent Vasovist™ (gadofosveset trisodium injection). In the filing, EPIX has asked that an Advisory Committee be considered as part of the appeal process. The company expects that the CDER director will respond to its submission within approximately 30 days, although any decision could be postponed until an Advisory Committee meeting if CDER grants the company’s request for one.
