
Ortho-McNeil, Inc. has filed a supplemental new drug application with the FDA for new indications of levofloxacin (Levaquin), 750 mg tablets: acute pyelonephritis and complicated urinary tract infections. The filing is based on a clinical trial evaluating the safety and efficacy of IV/oral levofloxacin, 750 mg once daily for 5 days, compared with IV/oral ciprofloxacin (Cipro), 500 mg twice daily for 10 days, in more than 1,100 patients with acute pyelonephritis or complicated UTIs.