Galderma Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for Differin Gel (adapalene gel 0.1%) as an over-the-counter (OTC) treatment for acne—the first and only OTC acne product containing a full prescription-strength retinoid. It also marks the first new, FDA-approved active ingredient to be introduced to the OTC acne category in more than three decades. Differin Gel is a once-daily topical indicated to treat current and future breakouts in people age 12 and older. The 0.1% adapalene gel is clear, fragrance-free, oil-free and alcohol-free.
“We believe bringing Differin Gel over-the-counter will be a game-changer for consumers and for the acne category,” said Miles Harrison, president and general manager of Galderma Laboratories. “We’re excited to deliver this new level of efficacy without a prescription to consumers, and to bring the first new active ingredient to the category in over 30 years.”