Mylan Inc. today announced that it, along with Famy Care Ltd., has entered into a settlement agreement with Warner Chilcott resolving litigation related to Femcon Fe Chewable Tablets, known generically as Norethindrone and Ethinyl Estradiol Tablets USP (Chewable), 0.4 mg/0.035 mg and Ferrous Fumarate Tablets USP (Chewable), 75 mg (28-Day Regimen). This medication is an oral contraceptive.
Pursuant to the settlement agreement, the pending litigation has been dismissed and Mylan may begin to market and sell a generic version of Femcon Fe upon receipt of final product approval from the U.S. Food and Drug Administration.
Additional details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Norethindrone and Ethinyl Estradiol Tablets USP (Chewable), 0.4 mg/0.035 mg and Ferrous Fumarate Tablets USP (Chewable), 75 mg, had U.S. sales of $44 million for the 12 months ending June 30, 2011, according to IMS Health.