News Release Detail

April 5, 2004

Mylan Announces Tentative Approval for Risperidone Tablets; Potential First-to-File Opportunity

Mylan Announces Tentative Approval for Risperidone Tablets; Potential First-to-File Opportunity

PITTSBURGH, Apr 5, 2004 (BUSINESS WIRE) -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Risperidone Tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Risperidone is the generic version of Janssen Pharmaceutica's Risperdal® Tablets.

Risperidone is one of ten potential first-to-file opportunities for Mylan currently before the FDA.

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.

SOURCE: Mylan Laboratories Inc.

Mylan Laboratories Inc.
Kris King, 724-514-1800
Customize your Business Wire news & multimedia to match your needs.
Get breaking news from companies and organizations worldwide.
Logon for FREE today at www.BusinessWire.com.