A 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庐 and Epiduo庐 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
ZUG, Switzerland--(BUSINESS WIRE)--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.
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鈥憈o鈥慜TC 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.
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“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鈥慴ased actives: adapalene, a highly stable and well鈥憈olerated 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鈥憀ine, 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.” |
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BILL ANDRIOPOULOS, PH.D. |
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HEAD OF GLOBAL MEDICAL AFFAIRS |
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GALDERMA |
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