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

The FDA has approved Differin Gel 0.1% (adapalene) for the over-the-counter (OTC) treatment of acne in patients aged 12 years or older.

Differin Gel 0.1%, a once-daily topical gel, is the first retinoid to be approved for OTC use in acne treatment. It was originally approved in 1996 as a prescription medication to treat acne vulgaris in patients aged 12 years or older.

“Millions of consumers, from adolescents to adults, suffer from acne,” said Lesley Furlong, MD, 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.”

The medication should be applied once daily in a thin layer over the affected areas of skin. It is for external use only, and it should not be used on damaged skin. Patients should follow the Drug Facts label for proper use and should consult their healthcare providers if their symptoms do not improve.

Women who are pregnant, planning to become pregnant, or breast-feeding should consult a clinician before use. Although there have been no adequate studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that it causes birth defects.

Reference

1. FDA approves Differin Gel 0.1% for over-the-counter use to treat acne [news release]. Silver Spring, MD: U.S. Food and Drug Administration; July 8, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm. Accessed July 25, 2016.