FDA Approves Antibiotic Ointment for Children and Adults

The Food and Drug Administration (FDA) approved Altabax (retapamulin ointment) for topical treatment of impetigo, a skin infection caused by bacteria. Altabax is indicated for use in patients aged nine months or older. Retapamulin is a new molecular entity (NME) not previously approved in the United States.

Altabax was approved on the basis of effectiveness data from a placebo-controlled study supported by a study comparing Altabax to another antibiotic. The safety database contained approximately 2,000 Altabax-treated adults and children aged nine months and older, and about 1,000 similar patients who received different antibiotics or placebo. The most common Altabax-related adverse event was irritation at the site of the application, which occurred in less than two percent of the patients.

To reduce the development of drug-resistant bacteria, and maintain the effectiveness of Altabax and other antibacterial drugs, this product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. This product will be available by prescription.

Altabax is manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709.

SOURCE: U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research