Bystolic
Generic name: nebivolol
Treatment for: High Blood Pressure
Mylan's NDA for Nebivolol Accepted for FDA Review
PITTSBURGH, July 01, 2004 -- Mylan Laboratories Inc. (NYSE:MYL) 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.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Mylan Bertek Pharmaceuticals Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.
For further information, please visit www.mylan.com
Posted: July 2004
Related articles
- Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension - December 18, 2007
- FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension - December 3, 2007
- 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 Submits New Drug Application for Nebivolol - May 5, 2004
Bystolic (nebivolol) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
