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Galderma Received FDA Approval of Differin(R) (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation
Date:3/22/2010

FORT WORTH, Texas, March 22 /PRNewswire/ -- Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration (FDA) approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% will be available by prescription in April 2010.

Differin Lotion, 0.1% is formulated for tolerable efficacy, spreads easily and is available in a convenient, easy-to-use pump dispenser. Differin Lotion, 0.1% is indicated for the treatment of acne vulgaris in patients 12 years and older, and can be used on the face and other areas of the body affected by acne.

Approval was based on two 12-week, multicenter, controlled clinical studies of similar design, comparing Differin Lotion, 0.1% to vehicle in 2,141 total acne subjects. In Study 1, 1,075 subjects were randomized to Differin Lotion, 0.1% or vehicle. At baseline, subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. In Study 2, 1,066 subjects were randomized to Differin Lotion, 0.1% or vehicle. At baseline, subjects had the same inclusion criteria as in Study 1. Differin Lotion, 0.1% was shown to show statistically significant reductions in total, inflammatory, and non-inflammatory lesion count at week 12 compared to vehicle, respectively.


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SOURCE Galderma Laboratories, L.P.
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