US Pharm. 2016;41(8):12.
Silver Spring, MD—The FDA has approved Differin Gel 0.1% (adapalene; Galderma Laboratories), a once-daily topical gel, for the OTC treatment of acne. It contains the first new active ingredient for nonprescription acne therapy to be introduced since the 1980s. While topical retinoid products are often prescribed first-line, Differin is the first retinoid acne treatment to be made available OTC. The product was originally approved in 1996 as a prescription drug for the treatment of acne vulgaris in patients aged ≥12 years. To support approval for OTC marketing, data from 1996-2016 postmarketing safety and consumer use studies were submitted. Acne is very common and affects approximately 50 million people in the United States.
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