Fougera, a specialty manufacturer of dermatologic and ophthalmic pharmaceuticals, recently announced that it has received tentative FDA approval to introduce the first generic version of Metronidazole Topical Gel USP 0.75%. The patent on the branded product by Galderma expires on June 6, 2006.
MetroGel® generated approximately $75 million in sales in 2004. It is indicated for the treatment of rosacea.
MetroGel® represents the eighth FDA approval and the third first-generic for Fougera thus far in 2005. “Our success in developing and marketing a consistent stream of topical products is gratifying. We continue to set the standard for bringing products our customers desire,” stated Dave Klaum, Sr. Vice President Commercial Operations.
