Regulatory Actions

FDA Approves Antibiotic Ointment for Children and Adults

Published in Medical Letter on the CDC and FDA, April 29th, 2007

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...

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Source: Medical Letter on the CDC and FDA (2007-04-29)

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