Differin Gel approved for OTC treatment of acne

WASHINGTON -- The U.S. Food and Drug Administration on Friday approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne.

Differin Gel 0.1% is approved for use in people 12 years of age and older.

Differin Gel 0.1% is the first in a class of drugs known as retinoids to be made available OTC for the treatment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin Gel 0.1% was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.

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

Differin Gel 0.1% is the first retinoid acne treatment to be made available OTC. Differin Gel 0.1% is distributed by Galderma Laboratories, L.P., based in Fort Worth, Texas.