Factive to receive AC review
Executive Summary
FDA's Anti-Infective Drugs Advisory Committee will review Oscient Pharmaceuticals' sNDA for Factive (gemifloxacin) Sept. 12 for five-day treatment of acute bacterial sinusitis, the company says June 28. The agency initially refused to file the application in January, citing the antibiotic's risk/benefit profile and particularly an increased risk of rash. However, following discussions with Oscient, FDA eventually agreed to file. The ABS indication has a Dec. 15 user fee date...