Medical Letter on the CDC & FDA
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Regulatory Actions
FDA Approves Antibiotic Ointment for Children and Adults
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...
Source: Medical Letter on the CDC & FDA (2007-04-29)
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