Biopure Hemopure user fee
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA extends review period for Biopure's Hemopure (hemoglobin glutamer-250 bovine) by three months to review mid-May amendment, setting the user fee goal date at Aug. 29. Biopure characterizes the submission as "additional analyses of previously submitted data." Hemopure was submitted July 31, 2002 for the treatment of acutely anemic patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell transfusions. The BLA contains clinical data from a U.S. Phase III orthopedic surgery trial and a non-U.S. Phase III non-cardiac surgery tria