Mylan Receives Approval for Buspirone 15 mg.

Business/Health Editors

PITTSBURGH--(BUSINESS WIRE)--March 28, 2001

Mylan Laboratories Inc. (NYSE:MYL) announced today that it has received approval from the Food and Drug Administration to manufacture and market Buspirone Hydrochloride Tablets 15 mg. As the first company to file a Paragraph IV certification, Mylan will be entitled to 180 days of exclusivity on this dosage form.

Buspirone is the generic equivalent of Bristol-Myers Squibb's ("BMS") BuSpar(R) Tablets, which is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.

Today's approval comes after extensive legal maneuvering by BMS. Mylan had anticipated launching the 15 mg buspirone product on November 22, 2000, when pediatric exclusivity was scheduled to expire. On November 21, 2000, BMS submitted patent information on U.S. Patent No. 6,150,365 ("'365") for listing in the Orange Book. Mylan filed a complaint against the Secretary of Health and Human Services, the United States Food and Drug Administration and Bristol-Myers Squibb Co. in the U.S. District Court for the District of Columbia. On March 13, the Court ordered BMS to request the FDA to remove the `365 patent from the Orange Book and also ordered the FDA to grant immediate approval to Mylan's product. In response to a motion filed by BMS for a stay of the District Court's order pending appeal, the U.S. Court of Appeals for the Federal Circuit entered a temporary stay, while it reviewed the submissions of the parties. The Federal Circuit lifted its temporary stay on March 27, 2001, concluding that BMS had "not established a likelihood of success on the merits." On March 28, BMS requested the FDA to remove its patent from the Orange Book and the FDA then granted final approval to Mylan's product.

Mike Puskar, Chairman and CEO commented "Mylan has overcome significant legal and regulatory obstacles to bring buspirone to the marketplace. Today, Mylan won a significant victory for our industry as well as the consumer. We are proud of this important approval and the financial benefits it will bring to American consumers."

Mylan will launch the buspirone 15 mg product immediately. The financial impact of this product will not significantly impact our 4th quarter results due to the limited shipping days remaining.

Mylan Laboratories Inc. is a leading pharmaceutical company that develops, manufactures and markets generic and proprietary prescription pharmaceutical products. The Company markets an extensive line of generic products through three business units, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., and UDL Laboratories, Inc. and branded products through its Bertek Pharmaceuticals Inc. subsidiary. These products are manufactured and sold in a variety of dosage forms including immediate and extended-release oral tablets and capsules and transdermal patches as well as repackaging and marketing multi-source and single-source products in unit dose form. For more information, visit www.mylan.com.

Certain statements in this release concerning the manner in which the Company intends to conduct its future operations and potential trends that may impact future results of operations are forward-looking statements. The Company may be unable to realize its plans and objectives due to various factors, including, but not limited to, the factors described under the heading "Forward Looking Statements" in Item 7 of the Company's Annual Report on Form 10-K for the year ended March 31, 2000 and under the heading "Year 2000" in Item 2 of its Quarterly Report on Form 10-Q for the quarter ended December 31, 2000. This disclosure may be accessed through the Website maintained by the SEC at http://www.sec.gov or, upon request made to Investor Relations, Mylan Laboratories Inc., 1030 Century Building, 130 Seventh Street, Pittsburgh, Pennsylvania 15222, telephone [phone], the Company will provide a copy of this disclosure to you without charge.