Watson Pharmaceuticals has confirmed the filing of ANDA with FDA by Watson Laboratories seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets, 1mg/0.01mg and 0.01mg and 75mg.
The product is a generic version of Warner Chilcott Company's Lo Loestrin Fe, indicated for use by women to prevent pregnancy.
Warner Chilcott filed suit against Watson in the US District Court for the District of New Jersey seeking to prevent Watson from commercializing its ANDA product prior to the expiration of US patents.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiff received notice of Watson's ANDA filing or until final resolution of the matter before the court, subject to any other exclusivities.
