Bystolic
Generic name: nebivolol
Treatment for: High Blood Pressure
Mylan Submits New Drug Application for Nebivolol
Pittsburgh, PA - May 5, 2004 – Mylan Laboratories Inc. (NYSE: MYL) announced today 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.
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.
Hypertension (high blood pressure) is a significant health risk affecting more than 50 million Americans1, and there is a 90% residual lifetime risk of developing hypertension in persons who reach the age of 65.2
Mylan Vice Chairman and CEO, Robert J. Coury stated, “We are committed to developing new and improved therapeutic options, and are very excited that nebivolol, when approved, will be a valuable addition to the current treatment regimen for hypertension.”
Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in 2001. Nebivolol is already registered and successfully marketed in more than 45 other countries outside of North America.
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.
REFERENCES
1. American Heart Association, Heart and Stroke Statistical Update, 2004.
2. JAMA 2002;287(8):1003-10.
Source: Mylan Laboratories Inc.
Posted: May 2004
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- Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol - May 1, 2007
- Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol - June 1, 2005
- FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005 - February 25, 2005
- Mylan's NDA for Nebivolol Accepted for FDA Review - July 1, 2004
Bystolic (nebivolol) FDA Approval History
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