Galderma announced that the U.S. Food and Drug Administration (FDA) has approved Differin Epiduo Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care.
With the approval of Differin Epiduo OTC, Galderma is bringing its proven acne science to a broader population of acne sufferers through wider access to a dermatologist-recommended, prescription-strength treatment, while further strengthening its global leadership in acne care.
Differin Epiduo is a topical acne treatment that combines adapalene, a third-generation retinoid originally discovered and developed by Galderma to address the stability and tolerability challenges of earlier retinoids, with benzoyl peroxide (0.1/2.5%). Together, these two dermatologist-trusted ingredients address key biological drivers of acne—clearing clogged pores, killing acne-causing bacteria, and reducing acne inflammation—to help clear acne, prevent future breakouts and improve skin tone, texture, and overall appearance. “This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science," says Bill Andriopoulos, PH.D., head of global medical affairs, Galderma. "Differin Epiduo pairs two complementary, evidence‑based actives: adapalene, a highly stable and well‑tolerated retinoid developed by Galderma, and benzoyl peroxide, a proven antimicrobial agent. This retinoid-benzoyl peroxide combination aligns with dermatology guidelines, which strongly recommend using both together as a first‑line, multimodal approach to acne treatment. Bringing this scientifically grounded combination to the OTC setting allows us to extend that legacy to patients across the U.S. while preserving the clinical rigor that underpins its effectiveness.”