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FDA approves Bystolic, a novel beta blocker

The U.S. Food and Drug Administration (FDA) has approved Bystolic (nebivolol) for the treatment of hypertension, also known as high blood pressure. Hypertension affects approximately 72 million adults in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range (blood pressure <140/90 mmHg), underscoring the need for additional therapeutic options.

Bystolic, a novel beta blocker, is a once-daily medication that can be used as monotherapy or in combination with other anti-hypertension treatments to reduce blood pressure with a low incidence of traditional beta blocker side effects. Bystolic works differently than many older beta blockers in that it is preferentially beta 1 selective at doses less than or equal to 10 mg, meaning it selectively blocks the effects of adrenaline at the heart. In addition, Bystolic vasodilates or widens and expands - the blood vessels.

Bystolic, marketed in the U.S. by Forest Laboratories, Inc (NYSE: FRX), will be available in pharmacies nationwide in January 2008. For additional information, visit or call 1-800-678-1605.

Hypertension Statistics:

  • The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025

  • Some individuals are at increased risk based on age, race, lifestyle, body mass index/obesity and family history

  • More than half of all Americans aged 60 and older have high blood pressure

  • Men over the age of 45 are at increased risk

  • Women over the age of 55 are at increased risk

  • Hypertension greatly increases the risk of certain health problems such as stroke, heart attack and kidney failure

  • Blacks are at a greater risk for developing hypertension than Caucasians

  • Most patients need two or more classes of hypertension medications to effectively control their condition


Contact: Maria Dottori
Fleishman-Hillard, Inc.

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