Bystolicâ„¢ (nebivolol): New Beta Blocker, FDA-Approved

Filed in archive Cardiovascular Health , FDA Approvals , Treatment on December 21, 2007

Sponsored by Mylan Bertek Pharmaceuticals Inc. and sold and marketed by New York City-based Forest Laboratories, Inc. - Bystolicâ„¢ (nebivolol) - has recently been approved by the FDA for the treatment of high blood pressure.




Beta blockers are well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps, while Bystolicâ„¢ (nebivolol) is a new drug not previously approved in the United States.

The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.

A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control.

In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.

Well, there goes one more drug option for the treatment of high blood pressure -the silent killer.

Source: FDA News; Forest Labs PR