Mylan Laboratories Inc 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.
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 per cent residual lifetime risk of developing hypertension in persons who reach the age of 65.
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.