FDA Gives New Beta Blocker for Hypertension the Green Light


December 18, 2007

December 18, 2007 - Forest Laboratories Inc. and Mylan Inc. announced today that the FDA cleared the novel beta blocker Bystolic (nebivolol) for the treatment of hypertension.

Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments.

In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects.

Like other beta blockers, Bystolic decreases heart rate and myocardial contractility and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.

"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, M.D., professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

For more information: www.bystolic.com