Mylan Announces FemconÂ® Fe Settlement Agreement
PITTSBURGH, Oct. 19, 2011 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that it, along with Famy Care Ltd., has entered into a settlement agreement with Warner Chilcott resolving litigation related to FemconÃ‚® 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
This press release includes statements that constitute “forward-looking statements,” including with regard to the settlement and the marketing of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company’s periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
SOURCE Mylan Inc.