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Wednesday 19 September 2007
FDA Approves Levaquin Short-Course Therapy
The FDA has approved the use of the five-day, once-daily regimen of Johnson & Johnson’s (J&J) Levaquin 750 mg for the treatment of complicated urinary tract infections and acute pyelonephritis.
The approval is based on results of a double-blind, randomized clinical trial by J&J and its subsidiary Ortho-McNeil involving 1,109 patients assessing the efficacy and safety of Levaquin (levofloxacin) versus Cipro (ciprofloxacin).
Microbiologic eradication and clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both the Levaquin and Cipro groups.