News Release Detail

July 2, 2002

Mylan Receives Approval for Lisinopril and Lisinopril/HCTZ

Mylan Receives Approval for Lisinopril and Lisinopril/HCTZPITTSBURGH, Jul 2, 2002 (BUSINESS WIRE) -- Mylan Laboratories Inc. (NYSE: MYL) announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Applications (ANDAs) for Lisinopril Tablets in 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg strengths and Lisinopril and Hydrochlorothiazide Tablets in 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg strengths.

Mylan's Lisinopril is the generic equivalent of AstraZeneca's Zestril® Tablets and Merck's Prinivil® Tablets. Mylan's Lisinopril and Hydrochlorothiazide is the generic equivalent of AstraZeneca's Zestoretic® Tablets and Merck's Prinzide® Tablets. Lisinopril and Lisinopril/HCTZ are indicated for the treatment of hypertension. In addition, Lisinopril is also indicated as an adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis and in the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival.

Both products were shipped immediately upon FDA approval.

Mylan Laboratories Inc., is a leading pharmaceutical company that develops, manufacturers 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. For more information, visit .

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking statements regarding our anticipated financial results and estimates, business prospects and products in research and under going development, all of which involve substantial risks and uncertainties. Such risks and uncertainties are not predictable or quantifiable; consequently, should known or unknown risks or uncertainties materialize, or should our assumptions or estimates prove inaccurate, actual results could differ materially from those expressed or implied by such forward-looking statement. For further details and a discussion of such risks and uncertainties, we encourage you to read Forward-looking Statements found in our Annual Report on Form 10-K for the fiscal year ended March 31, 2002, and in our periodic reports on Forms 10-Q and 8-K (if any).

We assume no obligation to update any forward-looking statements presented here today, whether as a result of new information, future events or otherwise.

CONTACT:          Mylan Laboratories Inc., Pittsburgh
                  Patricia Sunseri, 412/232-0100

Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
Copyright (C) 2002 Business Wire.  All rights reserved.
Email Alerts
Investor FAQs
Contact Us