FDA Approves Levaquin Short-Course Therapy Treatment

RARITAN, N.J. The Food and Drug Administration has approved the use of the five-day treatment regimen for people who suffer from urinary tract infections and acute pyelonephritis.

The approval is based on the results of a double blind, randomized clinical trial. Ortho-McNeil, creator of Levaquin, tested the stronger dosage of its oral treatment on  more than 1,000 patients. Both treatment groups demonstrated the resolution of, or improvement in, urinary symptoms with the drug’s stronger dosage (750 mg/once daily/five days).

“The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of cUTI andu of the David Geffen School of Medicine at UCLA. "Patients do not always finish a longer course of antibiotics. A shorter course of antibiotics 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., according to statistics. Furthermore, it is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.

Levaquin, which was introduced to the market in 1996, is used to treat bacterial infections caused by susceptible pathogens. Aside from treating urinary tract infections and acute pyelonephritis, Levaquin has also been used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, two forms of pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections (mild to moderate), and more.  

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