The FDA has approved use of J&J’s five-day, once-daily regimen of Levaquin 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

The approval is based on results from a double-blind, randomized trial involving 1,109 patients with either cUTI or AP, which assessed the efficacy and safety of Levaquin versus ciprofloxacin (Cipro). Clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin and Cipro groups.

Ortho-McNeil, Inc., along with Johnson & Johnson PRD, conducted the trial and the safety profile of Levaquin is similar across doses. Levaquin is marketed by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil.