FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

Zug, Switzerland – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (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.

unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older

Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin and Epiduo heritage

Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter

The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone

This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of 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.

Delivering continued innovation in acne prevention and 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%). This adapalene molecule reflects Galderma’s long-standing leadership in retinoid science, delivering an innovation-led approach that goes beyond traditional OTC acne actives. 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.1,2

The formulation is further powered by its Simulgel™ Gel Base, which stabilizes and evenly distributes both active ingredients while maintaining benzoyl peroxide’s efficacy and improving overall tolerability. This enables a simple, one-pump, once-daily regimen – a level of ease that is critical to building consistent routines and achieving clearer skin over time.

“This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science. 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.” BILL ANDRIOPOULOS, PH.D., HEAD OF GLOBAL MEDICAL AFFAIRS, GALDERMA

Clinical data supporting the approval demonstrated:

Proven efficacy across multiple randomized, controlled Phase 3 studies, with adapalene/benzoyl peroxide gel consistently outperforming adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates (“clear” or “almost clear”).3-5

Clinically meaningful improvement in lesion counts seen as early as Week 1, with antimicrobial activity beginning on Day 1 and up to 70.3% reduction in inflammatory acne lesions at Week 12.3

Sustained efficacy with long‑term use, maintaining ~65% total lesion reduction in a single arm study through 12 months, which supports once‑daily, ongoing acne control.6

Proven efficacy across diverse patient populations, with consistent results and favorable tolerability across skin tones.

“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. In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.” HEATHER WOOLERY-LLOYD, MD, BOARD-CERTIFIED DERMATOLOGIST, UNITED STATES

First approved as a prescription treatment, Epiduo® (Adapalene 0.1% and Benzoyl Peroxide 2.5%) Gel has been trusted by dermatologists for more than 15 years, with millions of prescriptions written worldwide. Its global clinical legacy includes more than ten Galderma studies involving over 3,200 patients, along with extensive third-party studies, across a wide range of ages, skin tones and acne severity. With this Prescription-to-OTC switch, Galderma continues to play a defining role in shaping modern acne care, leveraging its own proprietary science to advance dermatology, and expanding access to effective treatments.

Differin Epiduo will be available over-the-counter at most major retailers, including Walmart, Ulta, Target and Amazon, beginning in the summer of 2026. With a commitment to providing effective solutions across consumers’ acne journey, the Differin portfolio also includes cleansers, treatments, and moisturizers to support and provide wholistic solutions. For more information on Differin Epiduo and other Differin products, please visit www.differin.com and join the Differin community on Instagram, Facebook and YouTube to stay up to date on the latest innovations.

* Outside of the U.S. Epiduo® remains a prescription only product.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ—the skin—meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

Reynolds RV et al. J Am Acad Dermatol. 2024. doi:10.1016/j.jaad.2023.12.017.

Del Rosso JQ, J Clin Aesthet Dermatol. 2015.

Gollnick HP et al. Br J Dermatol. 2009;161(5):1180-1189.

Stein Gold L et al. Cutis. 2009;84(2):110-116.

Thiboutot DM et al. J Am Acad Dermatol. 2007;57(5):791-799.

Pariser et al JDD 2007 Sep;6(9):899-905.

Source: Galderma

Source: HealthDay

Differin Epiduo Acne Gel (adapalene and benzoyl peroxide) FDA Approval History

More news resources

FDA Medwatch Drug Alerts

Daily MedNews

News for Health Professionals

New Drug Approvals

New Drug Applications

Drug Shortages

Clinical Trial Results

Generic Drug Approvals

Drugs.com Podcast

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Posted : 2026-05-25 16:58

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.