Prescription to Over-the-Counter Transition
Galderma announced that the U.S. Food and Drug Administration (FDA) has approved Differin Epiduo Acne Gel for over-the-counter sale, effective from May 22, 2026. This approval allows individuals aged 12 and older to access the treatment without a prescription.n
The Differin Epiduo gel, combining adapalene 0.1% with benzoyl peroxide 2.5%, marks a significant Prescription-to-OTC transition. It targets multiple acne causes and expands access to a dermatologist-trusted treatment for millions of acne sufferers.n
“This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science,” stated Bill Andriopoulos, Ph.D., Head of Global Medical Affairs at Galderma.n
Clinical Efficacy and Availabilityn
Clinical trials have shown the efficacy of Differin Epiduo gel, with significant acne lesion improvement as early as one week. By week 12, up to a 70.3% reduction in inflammatory acne lesions was observed.n
Starting in summer 2026, the gel will be available at major U.S. Retailers, including Walmart, Ulta, Target, and Amazon. Galderma’s Differin portfolio supports consumers with additional products like cleansers and moisturizers.n
“This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription,” commented Heather Woolery-Lloyd, MD, a board-certified dermatologist in the U.S.n
Galderma’s Differin Epiduo is a topical treatment combining adapalene, a third-generation retinoid, with benzoyl peroxide. This approach targets key biological drivers of acne, such as clogged pores and acne-causing bacteria, going beyond traditional OTC acne actives.n
While Differin Epiduo is transitioning to over-the-counter status in the U.S., it remains prescription-only outside the country. Galderma continues to leverage its scientific expertise to advance dermatology and improve accessibility to effective acne treatments.
Last updated: 29 June 2026, 12:00 pm
