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FDA Approves Expanded Indication of Topical Acne Treatment

The FDA approved the expanded indication of dapsone (Aczone) 7.5% gel for the treatment of acne among patients aged 9 to 11 years. Dapsone was previously approved for the treatment of acne in patients aged 12 years and older in February 2016.

Approval for the expanded indication was based on data from an open-label study that assessed the safety, pharmacokinetics, and efficacy of dapsone 7.5% among 101 patients aged 9 to 11 with acne vulgaris. Findings from the study showed the therapy was safe and effective.
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Common adverse reactions associated with dapsone 7.5% gel include dryness and pruritus at the application site. Methemoglobinemia has been reported in post-marketing use of topical dapsone.


Aczone® (dapsone) gel, 7.5% now approved for the topical treatment of acne vulgaris in patients 9 years of age and older [press release]. Exton, PA: Almirall; September 10, 2019. September 11, 2019


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