FDA approves Galderma acne drug for over-the-counter use

Galderma announced July 8 its Fort Worth-based U.S. affiliate, Galderma Laboratories LP, has received approval from the U.S. Food and Drug Administration (FDA) for Differin Gel as an over-the-counter treatment for acne.

According to the company, the approval makes Differin Gel the first and only over-the-counter acne product containing a full prescription-strength retinoid. It also marks the first new, FDA-approved active ingredient to be introduced to the over-the-counter acne category in over three decades, giving more people access to an acne option.

“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. As the research and development leader of medically proven dermatologic solutions, Galderma is proud to announce this innovation will be available for people with skin health needs.”

Acne is the most common skin condition in the United States, affecting up to 60 million teens and adults annually.

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“This landmark approval was years in the making at Galderma and demonstrates our ongoing commitment to individuals with dermatologic concerns such as acne,” said Philip Brown, senior vice president, medical and regulatory affairs for Galderma Laboratories. “Galderma will continue to partner with healthcare professionals and invest in Rx, over-the-counter and Aesthetic & Corrective medical innovations to enhance skin health.”