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Fougera® Announces First Generic Approval of Adapalene Cream 0.1% (Rx), Equivalent to Differin®
Date:7/6/2010

MELVILLE, N.Y., July 6 /PRNewswire/ -- E. Fougera & Co., a leading specialty pharmaceutical manufacturer, announced it has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx).  Fougera's Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

"Fougera's commitment to develop this first-to-market product as a cost-effective generic provides healthcare professionals the ability to prescribe a more affordable treatment, thereby making it accessible to more patients," said David Klaum, Sr. Vice President and General Manager of Fougera.

Adapalene Cream 0.1% is indicated for the treatment of acne vulgaris. Full Prescribing Information for Adapalene Cream 0.1% is available at www.fougera.com or can be requested by calling (800) 645-9833.

Important Safety Information

Adapalene cream 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common side effects reported with use of adapalene 0.1% products include itching, dryness, redness, stinging, burning, and scaling or peeling. Most adverse events reported were mild to moderate in severity, occurred early in treatment and decreased thereafter. Excessive exposure to sunlight and sunlamps should be avoided during treatment and use of s
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