EPIX Pharmaceuticals, Inc. To File Appeal With The Center For Drug Evaluation And Research For Vasovist(TM)

LEXINGTON, Mass.--(BUSINESS WIRE)--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it will submit a formal appeal to the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its novel blood-pool imaging agent Vasovist™ (gadofosveset trisodium injection). The company anticipates submitting the appeal in the first quarter of 2007.
MORE ON THIS TOPIC