The US FDA has approved the fluoroquinolone antibiotic Levaquin (levofloxacin) Tablets/Injection and Levaquin (levofloxacin in 5% dextrose) Injection to treat multi-drug resistant strains of Streptococcus pneumonia in community acquired pneumonia (CAP), a release from Ortho-McNeil Pharmaceutical said.

Data from Tracking Resistance in the United States Today (TRUST) demonstrated that 98 per cent of MDRSP isolates are susceptible to Levaquin. TRUST, the largest and most comprehensive respiratory pathogen surveillance study in the United States, has been conducted annually since 1997. In vitro activity does not necessarily correlate with clinical results.

"This approval is significant as it increases the flexibility that physicians have to treat patients with drug-resistant bacterial infections with a medication that has demonstrated proven safety and efficacy over time," said Thomas G Slama, clinical professor of Medicine, Indiana School of Medicine, Indianapolis.

Levaquin is indicated to treat mild-to-severe community acquired pneumonia (CAP) due to Staphylococcus aureus, Streptococcus pneumonia , Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumonia , Moraxella catarrhalis , Chlamydia pneumonia , Legionella pneumophila , or Mycoplasma pneumonia . Levaquin may be used to treat cap in a five-day, 750 mg once-daily dosing regimen called the Leva-pak. Levaquin is also approved to treat CAP at a dose of 500 mg daily for seven to 14 days.

Approximately four million people in the United States develop CAP each year. S. pneumonia is one of the primary bacteria that causes CAP. Multi-drug resistant S. pneumonia (MDRSP) is form of bacteria resistant to two or more therapeutic classes of antibiotics including penicillin, second-generation cephalosporins, macrolides, tetracyclines and sulfonamides. The presence of multi-drug resistant S. pneumonia has increased significantly over time and today represent up to 23 percent of all strains.

Ortho-McNeil Pharmaceutical Inc, a Johnson & Johnson company, markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology and migraine headaches.