Mylan Laboratories, Inc.

NDA submitted for nebivolol

Published in Biotech Law Weekly, June 4th, 2004

Mylan Laboratories, Inc., (MYL) announced that its branded-products subsidiary, Bertek Pharmaceuticals, Inc., has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for nebivolol for use in the management of hypertension (high blood pressure).

The application is based on data from more than 2000 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...

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Source: Biotech Law Weekly (2004-06-04)

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