MELVILLE, N.Y. The Food and Drug Administration has given E. Fougera & Co. approval for the first generic version of a topical drug for treating skin diseases, Fougera announced.
The Melville, N.Y.-based generic drug maker got the agency’s nod for imiquimod cream in the 5% strength, a generic version of Graceway Pharmaceuticals’ Aldara. The drug works by activating the body’s immune system to fight actinic keratosis, genital warts and superficial basal cell carcinoma.
Aldara had sales of $360 million in 2009, according to industry data.
As the first company to win approval for a generic version of the drug, Fougera will get six months of market exclusivity in which to compete directly with the branded version, under the terms of the Hatch-Waxman Act of 1984.