Mylan Announces the FDA's Acceptance of its Apomorphine NDA


PITTSBURGH--(BUSINESS WIRE)--Feb. 20, 2003--Mylan Laboratories Inc. (NYSE:MYL) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Apomorphine subcutaneous injection for use in the rescue of "off" episodes associated with Parkinson's disease (PD).

Bertek Pharmaceuticals, Mylan's branded product subsidiary, which will market and promote the product upon approval, completed the submission of the rolling NDA to the FDA December 31, 2002.

"Currently, there are no approved rescue therapies in the United States for Parkinson's patients who experience sudden and debilitating episodes of total or partial immobility, known as "off" periods," stated Louis J. DeBone, President and COO of Mylan Laboratories Inc. DeBone further noted, "This filing is further confirmation of our commitment and ability to develop new drugs that address unmet needs."

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, 412/232-0100

SOURCE: Mylan Laboratories Inc.

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02/20/2003 06:02 EASTERN