FDA approves Aczone Gel (dapsone) once a day to treat acne- Allergan
Allergan plc announced that the Company has received approval from the FDA to market Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. Aczone Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in just once-a-day application
For the Aczone Gel, 7.5% pivotal trials, the company studied 4,340 acne patients, demonstrating efficacy and tolerability. The new FDA product approval also offers just once-daily dosing and a new pump delivery system.
Comment:There is currently no therapeutically equivalent version of Aczone available in the United States.Aczone was originally approved as a treatment for acne in the US in 2005.