News Release Detail

November 25, 2003

Mylan Comments on Fentanyl Opportunity

Mylan Comments on Fentanyl OpportunityPITTSBURGH--(BUSINESS WIRE)--Nov. 25, 2003--Yesterday, Mylan Laboratories Inc. (NYSE:MYL) announced that its subsidiary, Mylan Technologies, Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its fentanyl transdermal system, which is bioequivalent to Alza Corporation's Duragesic®. Final approval was granted by the FDA notwithstanding patent litigation in the U.S. District Court for the District of Vermont and the grant of pediatric exclusivity to Alza for Duragesic. This approval confirmed Mylan's position that neither a 30 month stay, nor pediatric exclusivity, applied to Mylan to receive approval because Alza failed to sue within 45 days after receiving notice of Mylan's Paragraph IV certification. Mylan's final post-trial brief setting forth this position was filed by the close of business on Monday.

Vice Chairman and CEO Robert J. Coury stated, "We have always viewed fentanyl as a substantial opportunity for Mylan, its shareholders and the consumers. We intend to launch the product upon appropriate findings in the litigation but in no event later than when the Alza patent expires on July 23, 2004."

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 Company's view of the opportunity fentanyl represents and the timing of the product launch. 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: uncertainties regarding the pending litigation; uncertainties regarding market acceptance of and demand for the product in question; the potential costs and product introduction delays that may result from use of legal, regulatory and legislative strategies by the Company's competitors; the possible negative effects of any interruption of manufacturing at the production facility; the expending of substantial resources associated with the pending litigation; other uncertainties and matters beyond the control of management; and the other risks set forth 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.

    CONTACT: Mylan Laboratories Inc.
             Kris King, 724/514-1800

    SOURCE: Mylan Laboratories Inc.