FDA approves a new beta blocker

Dec 18, 2007

The U.S. Food and Drug Administration has approved Bystolic, a beta blocker, for the treatment of high blood pressure. Bystolic (nebivolol) is a new drug not previously approved for use in the United States.

Beta blockers are a well-established class of medications that reduce blood pressure by reducing the force with which the heart pumps, the FDA said. Nearly 1-in-3 adults in the United States suffers from hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.

The FDA said the safety and efficacy of Bystolic was assessed during 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.

More than 2,000 people received Bystolic during the trials, the FDA said, with the most common side effects reported being headache, fatigue, dizziness and diarrhea.

Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., is the sponsor of Bystolic. New York City-based Forest Laboratories Inc. owns the rights for marketing of the drug.

Copyright 2007 by United Press International

Explore further: National Cancer Institute supports next-generation Austrian HPV vaccine

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

A new tool in drug overdose prevention

3 hours ago

The Center for Disease Control reported earlier this month that the heroin overdose death rate across 28 states it surveyed doubled between 2010 and 2012. This sharp increase and the chilling statistics that say more than 11 ...

Nasal spray treats heroin overdose

Oct 28, 2014

"Every year, drug overdoses are responsible for roughly 1000 ambulance calls in Oslo," says Arne Skulberg, an anaesthesiologist, a PhD candidate at NTNU and the 2014 winner of Norway's Researcher Grand Prix ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.