CAMBRIDGE, Mass., Aug. 14 (UPI) -- Epix Pharmaceuticals said Monday its Vasovist blood pool imaging agent has been recommmended for approval in Australia.
Final approval of the drug in Australia is subject to finalization of the product's labeling, the company said.
Vasovist is an injectable contrast agent used to provide visual imaging of the vascular system through magnetic resonance angiography, Epix said.
"The positive opinion on Vasovist (in Australia) is another important step forward for Epix," said Andrew Uprichard, the company's president and chief operating officer. "We were recently advised by the U.S. Food and Drug Administration (FDA) that the agency has extended its review of our appeal, and that we should hear its response in September. Meanwhile, Vasovist is gaining momentum in the European Union, and we expect that it will be available in fifteen countries by the end of this year."
Vasovist was approved in Europe in October 2005, where Schering AG, Epix's Vasovist marketing partner, launched the product in the second quarter of this year.
