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FDA approves Differin Gel 0.1% for over-the-counter use to treat acne

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The U.S. Food and Drug Administration today 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.”

Acne is a common skin disease that affects approximately 50 million people in the United States. Acne pimples form when hair follicles of the skin clog up. Generally, pimples form on the face, neck, back, chest and shoulders. Anyone can get acne, but it is most common in teenagers and young adults. Acne can cause scarring and have adverse psychological effects (for example, poor self-image, depression and anxiety). Several OTC and prescription treatment options are available for people with acne.

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