News Release Detail

July 10, 2003

Mylan's Apomorphine NDA Advances in FDA Review Process

Mylan's Apomorphine NDA Advances in FDA Review ProcessPITTSBURGH--(BUSINESS WIRE)--July 10, 2003--Mylan Laboratories Inc. (NYSE:MYL) announced today that its subsidiary, Bertek Pharmaceuticals Inc., has received an approvable letter from the Food and Drug Administration (FDA) for its New Drug Application (NDA) for apomorphine hydrochloride injection, 10mg/ml. Final approval of the NDA is dependent upon the submission of additional information requested by the FDA.

Bertek's NDA for apomorphine was accepted for filing by the FDA in January 2003 and was granted Fast Track status.

Bertek Pharmaceuticals Inc., based in Research Triangle Park, N.C., develops and licenses proprietary pharmaceuticals, with a current focus on dermatology, neurology and cardiology. For more information, visit www.bertek.com.

Mylan Laboratories Inc. is a leading pharmaceutical company that develops, manufactures and markets generic and proprietary prescription products. Mylan has two operating segments that market an extensive line of generic and branded products through four business units: Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc. For more information about Mylan, visit www.mylan.com.

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. We refer you to the risk factors and other disclosures contained in our periodic SEC filings. We undertake no duty to update our forward-looking statements, even though our situation may change in the future.

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

    SOURCE: Mylan Laboratories Inc.