Levaquin approved for treatment of complicated skin and skin structure infections

Approval represents ninth indication for the drug

The United States Food and Drug Administration (FDA) has approved Levaquin Tablets/Injection (levofloxacin tablets/injection) for the treatment of complicated skin and skin structure infections at a daily dose of 750 mg. The new indication is the ninth for Levaquin, which is already used in 500 mg and 250 mg doses to treat respiratory, urinary, and other types of skin infections. Levaquin is marketed in the United States by Ortho-McNeil Pharmaceutical Inc. (Raritan, NJ).

Complicated skin and skin structure infections include deep wounds, such as surgical incisions, bites and lacerations that have become infected, major abscesses, or infected ulcers. Levaquin is indicated to treat complicated skin and skin structure infections caused by methicillin-sensitive Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis. The recommended course of therapy for treatment of these infections is a single dose of Levaquin 750 mg—eitehr oral or intravenous—given once daily for seven to 14 days.

Results of a recently completed Phase III trial demonstrate the safety and efficacy of levofloxacin 750 mg once daily for the treatment of complicated skin infections. For the 270 clinically evaluable subjects, clinical success rates (cure + improved) were 84.1% in the levofloxacin treatment group, compared with 80.3% in the comparator treatment group, which received injectable ticarcillin/clavulanate, either alone or followed by oral amoxicillin/clavulanate.

Ortho-McNeil, a Johnson & Johnson company, markets pharmaceutical products in several therapeutic categories, including infectious diseases, central nervous system, wound healing, and women's health.

For more information: Ortho-McNeil Pharmaceutical Inc., 1000 Rte. 202 South, PO Box 300, Raritan, NJ 08869. Tel: 908-218-6000. Fax: 908-685-9032.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online