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FDA approves Differin gel 0.1% for over-the-counter acne treatment
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The FDA has approved Differin gel 0.1% for over-the-counter acne treatment for people aged 12 years and older, according to a press release from the FDA.
The approval of Differin (0.1% adapalene, Galderma Laboratories) once-daily topical gel is based on data from five clinical trials evaluating the gel in people with mild-to-moderate acne. The data included data accrued in a 20-year time span on post-marketing safety, data from consumer studies and submitted data from a maximal use trial.
“Millions of consumers, from adolescents to adults, suffer from acne,” Lesley Furlong, MD, deputy director of the Office of New Drugs IV in the FDA’s Center for Drug Evaluation and Research, said in the release. “Now consumers have access to a safe and effective over-the-counter option.”