FDA clears new indication for Ortho-McNeil's Levaquin

The US Food and Drug Administration has approved use of the five-day, once-daily regimen of Johnson & Johnson subsidiary Ortho-McNeil's Levaquin (levofloxacin) 750mg intravenous and oral, for the treatment of complicated urinary tract infections and acute pyelonephritis.

This latest approval is based on results of a double-blind, randomized clinical trial involving 1,109 patients with either cUTI or AP which assessed the efficacy and safety of Levaquin 75 mg/once daily/five days) versus ciprofloxacin (Bayer's Cipro) (400/500mg/twice-daily/10 days). Microbiologic eradication and clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin and ciprofloxacin groups.

"The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of cUTI and AP," said Richard David, associate clinical professor of urology at the David Geffen School of Medicine at UCLA. "Patients do not always finish a longer course of antibiotics. A shorter course of antibiotic offers patients the convenience of five-day, once-daily therapy," he added.