Talecris granted FDA priority review for Gamunex

The priority review designation is intended to expedite the review process for therapies that may provide a significant improvement in the treatment of serious or life-threatening diseases. Based on this priority review status, the FDA reviews the application with the goal of taking action within six months of the sponsor’s submission of supplemental biologics application.

Stephen Petteway, senior vice president, R&D for Talecris, said: “We are encouraged that the FDA has determined the application meets its criteria for such review, and look forward to working with the agency as it continues its review process.”