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: Pharmacists' group discourages providing execution drugs (Update)

Related Stories

Climate fund signs up first partners

18 minutes ago

The global fund created to spearhead climate change financing has selected its first partners to channel funds to developing countries, but says it needs donor nations to move fast in transforming cash pledges ...

Recommended for you

Teva buying Auspex for $3.2 billion

Mar 30, 2015

Teva Pharmaceutical Industries Ltd. is buying Auspex Pharmaceuticals Inc. for about $3.2 billion in a move to strengthen its position on central nervous system condition treatments.

Oral hepatitis B vaccine could become a reality

Mar 30, 2015

In a new study, researchers report progress toward perfecting a radical new method of producing vaccines using genetically modified corn. The approach could lead to an oral hepatitis B vaccine that requires no refrigeration ...

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.