Differin Gel 0.3% receives FDA approval

Journal of Drugs in Dermatology, August, 2007 by Marissa Heller

Galderma Laboratories, LP, recently announced that its product, Differin[R] (adapalene) Gel, 0.3%, has received approval from the FDA. This new product is a higher concentration of its current product, Differin Gel, 0.1%. Differin Gel is a topical retinoid that is approved for topical treatment of acne vulgaris.

The latest approval is based on a recent randomized, controlled, multicenter, double-blind trial that enrolled a total of 653 patients with moderate to moderately severe acne and demonstrated the safety and efficacy of Differin Gel, 0.3%. The study was recently published in the Journal of the American Academy of Dermatology; Volume 54, Issue 2, page 243. Side effects of treatment with this medication include skin irritation such as itching, dryness, redness, burning, or peeling.