The FDA has approved Altabax (retapamulin ointment) for topical treatment of impetigo, a skin infection caused by bacteria. Altabax is indicated for use in patients 9 months or older. Retapamulin is a new molecular entity (NME) not previously approved in the United States.
In a placebo-controlled study, 2,000 adults and children were treated with Altabax and 1,000 other patients received different antibiotics or placebos.
The results of the study indicated that the most common Altabax-related adverse effect was irritation at the site of the application, which occurred in less than 2% of patients.
[FDA, April 13, 2007]