FDA News

FDA Approves LEVAQUIN Short-Course Therapy for Treatment of Complicated UTI

(Sept 17, 2007)-- The U.S. Food and Drug Administration (FDA) has approved use of the five-day, once-daily regimen of LEVAQUIN (levofloxacin) 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) 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 (750 mg/once daily/five days) versus ciprofloxacin (Cipro) (400/500 mg/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 (750 mg/once daily/five days) and ciprofloxacin (400/500 mg/twice daily/10 days) 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, MD, FACS, Associate Clinical Professor of Urology, 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."

Each year, urinary tract infections account for more than eight million physician visits in the U.S. They occur in the kidneys, ureters, bladder or the urethra and often are recurrent, resulting in treatment with several courses of antibiotics. Complicated UTIs occur nearly as frequently in men as in women and often occur in people who are susceptible to bacterial infections because of a weakened immune system. Complicated UTIs also may be caused by structural or functional difficulties that interfere with the flow of urine, such as kidney stones.

Pyelonephritis is an infection of one or both kidneys caused by bacteria. It is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.

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