PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it and Famy Care Ltd. have been sued by Warner Chilcott Company LLP, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets, 0.8 mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This product is the generic version of Generess™ Fe, a 28-day regimen indicated for use by women to prevent pregnancy.
Mylan believes that this application submitted to the FDA is the first substantially complete ANDA containing a Paragraph IV certification and expects it to qualify for 180 days of marketing exclusivity upon final approval. In 2008, Mylan and Famy Care entered into a partnership to develop and supply oral contraceptives. Warner Chilcott filed the lawsuit in the U.S. District Court for the District of New Jersey.
Since launching in April 2011 and through Sept. 30, 2011, Generess Fe had sales of $4.5 million, according to IMS Health.
This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. 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: the use of legal, regulatory and legislative 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 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.
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.
SOURCE Mylan Inc.