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: More than a quarter of emergency contraceptives in Peru falsified or substandard

add to favorites email to friend print save as pdf

Related Stories

Quantenna promises 10-gigabit Wi-Fi by next year

1 hour ago

(Phys.org) —Quantenna Communications has announced that it has plans for releasing a chipset that will be capable of delivering 10Gbps WiFi to/from routers, bridges and computers by sometime next year. ...

A greener source of polyester—cork trees

1 hour ago

On the scale of earth-friendly materials, you'd be hard pressed to find two that are farther apart than polyester (not at all) and cork (very). In an unexpected twist, however, scientists are figuring out ...

Recommended for you

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments : 0

More news stories

Cancer stem cells linked to drug resistance

Most drugs used to treat lung, breast and pancreatic cancers also promote drug-resistance and ultimately spur tumor growth. Researchers at the University of California, San Diego School of Medicine have discovered ...

Poll: Big Bang a big question for most Americans

Few Americans question that smoking causes cancer. But they have more skepticism than confidence in global warming, the age of the Earth and evolution and have the most trouble believing a Big Bang created the universe 13.8 ...

Making graphene in your kitchen

Graphene has been touted as a wonder material—the world's thinnest substance, but super-strong. Now scientists say it is so easy to make you could produce some in your kitchen.