FDA Approves Differin Gel for Over-the-Counter Use

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FDA Approves Differin Gel for Over-the-Counter Use
FDA Approves Differin Gel for Over-the-Counter Use

MONDAY, July 11, 2016 (HealthDay News) -- The once-daily acne treatment Differin Gel 0.1% (adapalene) has been approved for over-the-counter use among patients 12 and older, the U.S. Food and Drug Administration said.

It's the first retinoid to be made available over the counter to treat acne. The drug's active ingredient is the first new over-the-counter acne treatment approved since the 1980s, the FDA said in a news release. Differin Gel 0.1% was first approved in 1996 as a prescription drug.

The agency warned that women who are pregnant, planning to become pregnant, or breastfeeding should get their doctor's approval before using the product. While no specific issues with pregnant or breastfeeding women using Differin Gel have been identified, some retinoid drugs have been shown to cause birth defects, the FDA said.

"Millions of consumers, from adolescents to adults, suffer from acne," Lesley Furlong, M.D., deputy director of the Office of New Drugs IV in the FDA's Center for Drug Evaluation and Research, said in a statement. "Now, consumers have access to a new safe and effective over-the-counter option."

Differin Gel 0.1% is distributed by Galderma Laboratories, based in Fort Worth, Texas.

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