Aczone Gel Receives Expanded Approval
September 10, 2019 – The U.S. FDA has approved an expanded indication for Aczone® 7.5% Gel, manufactured by Almirall LLC. The product is now indicated for use as a topical treatment for inflammatory and non-inflammatory patients in patients who are least nine years of age.
Aczone originally received FDA approval in February 2016 for patients 12 and older. The new expanded indication was granted based on an open-label safety study that found Aczone Gel to be safe and effective in patients 9 to 11 years of age who have acne vulgaris.
Recommended dosing is a pea-sized amount of gel applied in a thin layer to the entire face once per day. A thin layer can also be applied to other affected areas once daily if needed. Treatment with Aczone should be reassessed after 12 weeks and potentially discontinued if there has been no improvement in the patient’s acne.