FDA grants Fougera first generic approval for Adapalene Cream 0.1%

Jul 7 2010

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.