EPIX gets extension on FDA review of Vasovist

By Elaine Rigoli

Tampa, Fla., July 28 - EPIX Pharmaceuticals, Inc. said Friday that the Food and Drug Administration is extending its review of the formal appeal submitted by the company on June 30.

In the appeal, EPIX asked the FDA to approve the company's blood-pool imaging agent Vasovist and to use an advisory committee as part of the appeal process.

The FDA indicated that it expects to respond to the appeal in September.

"We appreciate the FDA's willingness to take this additional time to review our appeal of the Vasovist approvable letters," president and chief operating officer Andrew Uprichard said in a news release.

EPIX, based in Cambridge, Mass., develops pharmaceuticals for medical imaging modalities.

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