FDA APPROVES ONCE-DAILY LEVAQUIN FOR SINUSITIS

The FDA has approved a new five-day, 750 mg once-daily regimen for Levaquin (levofloxacin) tablets to treat acute bacterial sinusitis.

This regimen is available in the convenient Leva-pak and is the first and only short course fluoroquinolone regimen approved for the treatment of acute bacterial sinusitis. The approval is based on a clinical study that found this shorter treatment regimen as effective as a traditional regimen of Levaquin 500 mg for 10 days.

Sinusitis is one of the most common conditions seen by primary care physicians, and according to the National Ambulatory Medical Care Survey, is the fifth most common condition for which an antibiotic is prescribed. Each year in the U.S. there are an estimated 20 million cases of acute bacterial sinusitis.

The approval is based on a multicenter, randomized, double-blind clinical study that evaluated 780 adult outpatients diagnosed with acute bacterial sinusitis. The primary outcome measured in this study was the complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary. Levaquin is indicated for adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. These pathogens are the most common causes of acute bacterial sinusitis.