PITTSBURGH--(BUSINESS WIRE)--Dec. 11, 2003--Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has approved ERTACZO(TM) (sertaconazole nitrate) Cream, 2%. Sertaconazole is an imidazole derivative antifungal indicated for the treatment of Tinea Pedis.
In October 2003, Mylan announced the sale of the U.S. and Canadian rights for sertaconazole to the Ortho Neutrogena Division of Ortho-McNeil Pharmaceutical Inc. (Ortho Neutrogena), terminating the licensing rights it held to sertaconazole from Ferrer Internacional S.A. Mylan received $2 million upon signing the agreement with Ortho Neutrogena and will receive the additional $12 million as a result of the FDA's final approval of its NDA.
The product will be marketed by Ortho Neutrogena.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to the payment to be made to the Company and the marketing of sertaconazole. 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 contractual disputes with regard to the payment; uncertainties regarding market acceptance of, demand for and competition with regard to sertaconazole; potential product introduction delays; 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.
Mylan Laboratories Inc. Kris King, 724-514-1800