ACZONE? (DAPSONE) GEL, 7.5% NOW APPROVED FOR THE TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

发布时间： 2019-09-02 阅读：886次

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September 10, 2019 ― Almirall LLC announced today the FDA approval of the expanded indication for Aczone? 7.5% 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.

“Acne is linked to the onset of puberty, which may start earlier, and pre-teen children are an impressionable age group prone to the emotional and psychosocial implications of the disease. Almirall is therefore pleased to be able to offer this FDA approved treatment option which is proven to be safe and effective in children 9 to 11 years old,” states Ayman Grada, MD, Director of Medical Affairs and R&D at Almirall, LLC.

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.