Drug application filed for complicated UTIs, acute pyelonephritis

Jan 18, 2007

A supplemental new drug application has been filed with the FDA to support the use of levofloxacin (Levaquin) tablets for a 5-day, 750 mg once-daily regimen for the treatment of adults with mild, moderate, and severe complicated urinary tract infections and acute pyelonephritis.

A supplemental new drug application has been filed with the FDA to support the use of levofloxacin (Levaquin) tablets for a 5-day, 750 mg once-daily regimen for the treatment of adults with mild, moderate, and severe complicated urinary tract infections and acute pyelonephritis.

The application is based on clinical trial data involving more than 1,100 patients evaluating the efficacy and safety of IV/oral levofloxacin, 750 mg once daily for 5 days, compared with IV/oral ciprofloxacin, 500 mg twice daily for 10 days, in patients with complicated UTIs or acute pyelonephritis.

The application supports the use of levofloxacin, 750 mg, for complicated UTIs and acute pyelonephritis caused by Enterococcus faecalis; Enterobacter cloacae; Escherichia coli, including cases with bacteremia; Klebsiella pneumoniae; Proteus mirabilis; or Pseudomonas aeruginosa.