The FDA issued a warning letter to GlaxoSmithKline regarding promotional material for Altabax (retapamulin) that it claims was false or misleading because it "broadens the indication of [the drug], makes unsubstantiated superiority claims, and omits and minimizes important risk information associated with" the impetigo treatment.
In documents posted to the FDA's website on Tuesday, the agency said the marketing material suggests "Altabax is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience." The US regulator noted that the sales material implied the drug is effective in the treatment of impetigo caused by all strains of Staphylococcus aureus, including methicillin-resistant forms, when it is only approved to treat methicillin-susceptible strains.
The agency cited a footnote in the material which stated that Altabax was approved to treat "methicillin-susceptible isolates only," however the regulator noted that this was not enough to overcome the "misleading impression" created by the other claims in the brochure.
GlaxoSmithKline said it has responded to the FDA and is no longer using the sales brochure.
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