The U.S. Food and Drug Administration in August approved a new five-day,
750 mg once daily regimen for Levaquin (levofloxacin) tablets by
Ortho-McNeil to treat acute bacterial sinusitis. The regimen is the
first and only short-course fluoroquinolone regimen approved for the
treatment of acute bacterial sinusitis, according to a company press
release.

The FDA based the approval on a study that found that this treatment
regimen is as effective as a traditional regimen of Levaquin 500 mg for
10 days. The study involved 780 adult outpatients diagnosed with acute
bacterial sinusitis.

Levaquin is indicated for the treatment of adults with acute bacterial
sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae and
Moraxella catarrhalis, the most common causes of acute bacterial sinusitis.

Clinical success rates in the study were seen for 91.4% of patients in
the five-day group and 88.6% of patients in the 10-day group.

The five-day, 750 mg once daily regimen of Levaquin also is approved for
adults with community-acquired pneumonia caused by
penicillin-susceptible Streptococcus pneumoniae (excluding
drug-resistant strains), Haemophilus influenzae, Haemophilus
parainfluenzae, Chlamydia pneumoniae or Mycoplasma pneumoniae.

The most common adverse events in clinical trials were nausea and diarrhea.