FDA Approves Differin Gel for Over-the-Counter Use

Share this content:
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.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Study Provides Estimates of U.S. Prevalence of Type 1, 2 Diabetes

Study Provides Estimates of U.S. Prevalence of Type ...

Prevalence of type 1 diabetes 0.5 percent, type 2 diabetes 8.5 percent among U.S. adults

Black Individuals at Highest Risk of Legal Intervention Injury

Black Individuals at Highest Risk of Legal Intervention ...

Increase in rates of injuries from 2005 to 2009, followed by a drop to 2015, returning to ~2005 levels

Research Links Doctor Burnout to Patient Safety Incidents

Research Links Doctor Burnout to Patient Safety Incidents

Physician burnout linked to increased risk of patient safety incidents, reduced patient satisfaction

is free, fast, and customized just for you!




Already a member?

Sign In Now »