Perrigo files FDA application for OTC generic of Monistat

ALLEGAN, Mich. Perrigo on Monday announced that it has filed an abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream, 2 percent and Suppository, 1.2g, a generic version of Monistat 1 Combination Pack.

Monistat 1 Combination Pack is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc., Perrigo reported.

According to Perrigo, McNeil challenged Perrigo’s ANDA with a suit filed Friday alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product.