A Medical Device Daily

Epix Pharmaceuticals (Cambridge, Massachusetts) said the FDA has advised the company that it is extending its review of the formal appeal submitted on June 30.

In the appeal, Epix asked the agency to approve its 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,” said Andrew Uprichard, MD, Epix's president and COO. “We look forward to hearing the FDA's response to our appeal in September.”

Epix, a developer of pharmaceuticals for MRI, in April reported a definitive agreement to merge with Predix Pharmaceuticals Holdings (Lexington, Massachusetts).