FDA Approves OTC Switch for Galderma’s Differin Epiduo Acne Gel

Key Takeaways

• The FDA approved Galderma’s Differin Epiduo Acne Gel (adapalene 0.1%/benzoyl peroxide 2.5%) for over-the-counter use in patients aged 12 years and older, according to a statement from the manufacturer.
• The prescription-to-OTC switch expands access to a fixed-dose retinoid and benzoyl peroxide combination backed by more than 15 years of clinical use.
• Clinical studies demonstrated superiority versus adapalene alone, benzoyl peroxide alone, and vehicle across inflammatory and noninflammatory lesion endpoints.

The US Food and Drug Administration (FDA) has approved Galderma’s Differin Epiduo Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter (OTC) use in patients aged 12 years and older, marking a notable prescription-to-OTC transition in acne therapeutics, according to a news release from manufacturer Galderma. 

Originally approved as a prescription product, Epiduo combines adapalene, a third-generation retinoid developed by Galderma, with benzoyl peroxide in a fixed-dose topical formulation designed to address multiple pathogenic factors involved in acne vulgaris. According to the company, the formulation targets clogged pores, Cutibacterium acnes proliferation, and inflammation while supporting improvements in skin texture and tone.

Clinical Data Support OTC Availability of Adapalene/Benzoyl Peroxide Combination

Galderma stated that the approval was supported by multiple randomized Phase 3 clinical trials in which the adapalene/benzoyl peroxide combination outperformed adapalene monotherapy, benzoyl peroxide monotherapy, and vehicle gel across inflammatory lesions, noninflammatory lesions, total lesion counts, and Investigator Global Assessment success rates. The company also cited lesion count reductions observed as early as Week 1, with up to a 70.3% reduction in inflammatory lesions by Week 12. Long-term data reportedly demonstrated sustained efficacy through 12 months of use.

“This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science,” said Bill Andriopoulos, PhD, Head of Global Medical Affairs at Galderma, in the news release. Heather Woolery-Lloyd, MD, added that expanded OTC availability may help improve treatment consistency through easier access and a simplified once-daily regimen.

Differin Epiduo OTC is expected to launch in major US retailers (including Walmart, Ulta, Target, and Amazon), in summer 2026. 

Source

Galderma news release. May 22, 2026.