News | December 17, 2007

FDA Gives New Beta Blocker for Hypertension the Green Light

December 18, 2007 - Forest Laboratories Inc. and Mylan Inc. announced today that the FDA cleared the novel beta blocker Bystolic (nebivolol) for the treatment of hypertension.

Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments.

In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects.

Like other beta blockers, Bystolic decreases heart rate and myocardial contractility and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.

"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, M.D., professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

For more information: www.bystolic.com

Related Content

Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat
News | Pharmaceuticals | June 14, 2019
Quantum Genomics announced the enrollment of the first patient in its QUORUM Phase IIb study of its lead clinical...
FDA Grants Priority Review for Vascepa sNDA
News | Pharmaceuticals | May 29, 2019
Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has...
Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Overlay Init