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FDA approves Galderma’s stronger acne formulation

The FDA has approved Galderma Laboratories' topical acne treatment Differin Gel, 0.3%, a higher concentration formulation of Differin 0.1%.

The stronger formulation is efficacious enough to treat moderate to moderately-severe acne while still providing a favorable side effect profile, Galderma said. Differin Gel, 0.3% will be available by prescription by July 2007.

Albert Draaijer, president of Galderma USA, said: “Our clinical studies demonstrate that Differin Gel, 0.3% is effective in treating more severe cases of acne, while still offering the favorable tolerability profile which physicians and patients have come to expect from Differin. This combination of tolerability and efficacy will further improve outcomes for these patients.”

In a trial of 653 patients with moderate to moderately-severe acne in the US, both concentrations of adapalene gel were found to be well-tolerated but results revealed a clear dose-dependent response for all efficacy assessments. Differin Gel, 0.3% also demonstrated a fast onset of action as shown by significantly improved skin clearance as early as one week into the study, the company said.