FDA expands indication for Aczone for patients age 9 - 11 with acne
Almirall LLC announced the FDA approval of the expanded indication for Aczone 7.5% (dapsone gel) to include patients aged 9-11. Aczone 7.5% Gel is a prescription medicine used on the skin (topical) to treat inflammatory and non-inflammatory acne, previously approved in February 2016 for patients 12 and older.
The expanded approval was based on data from an open-label safety study to assess safety, pharmacokinetics, and treatment effect of Aczone Gel, 7.5% in 101 patients 9 to 11 years of age with acne vulgaris. Aczone 7.5% Gel was determined to be safe and effective in this patient population.
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