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FDA Accepts Nebivolol NDA For Review

PITTSBURGH, July 1 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its branded product subsidiary's, Mylan Bertek Pharmaceuticals Inc. (Mylan Bertek), New Drug Application (NDA) for nebivolol, for which the company is seeking approval for use in the management of hypertension.

"Based on the clinical trial data to date, we believe that nebivolol shows great promise as a valuable treatment for hypertension," stated Mylan Vice Chairman and CEO, Robert J. Coury. "Now that our nebivolol submission has been accepted by the FDA, we are excited to begin the review and approval process, and look forward to the addition of this exciting proprietary product to our growing brand franchise."

As previously stated, the application is based on data from more than 2,000 patients enrolled in clinical trials to demonstrate the efficacy and safety of nebivolol in lowering blood pressure in hypertensive patients regardless of age, race or gender when administered once daily. In vitro studies have demonstrated that nebivolol is a highly beta-1 selective (cardioselective) blocker, which also increases nitric oxide levels. In clinical trials nebivolol was well tolerated with an incidence of adverse events similar to that of placebo.

Mylan Bertek filed its NDA with the FDA April 28, 2004 and the FDA has provided an action date of February 28, 2005.

Source: Mylan Laboratories Inc.

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