Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
NEW YORK, December 18, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Mylan Inc. announced today that the novel beta blocker Bystolic (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. 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.
Beta blockers are one of the most widely used classes of drugs in the United States. 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, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."
Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
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.
Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the U.S. and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.
Forest expects Bystolic to be available to physicians, patients, and pharmacies in January 2008. Interested parties can register to receive immediate notification of Bystolic's availability, get more information on Bystolic, or obtain prescribing information by visiting www.Bystolic.com or by calling 1-800-678-1605.
Important Safety Information
Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a one to two week period and the patient carefully monitored.
Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
Like other beta blockers, Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. Caution should also be used in diabetic patients as beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
In general, patients with bronchospastic disease should not receive beta blockers.
Bystolic should not be combined with other beta blockers.
The most common adverse events with Bystolic were headache, fatigue and dizziness.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company dedicated to identifying, developing and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; and Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, Benicar HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, and AZOR* (amlodipine and olmesartan medoxomil) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' and Mylan's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
CONTACT: Charles E. Triano, Vice President - Investor Relations of ForestLaboratories, Inc., +1-212-224-6714, , or Liesel Enkeof Fleishman-Hillard, +1-212-453-2427, , forForest Laboratories, Inc. Charles.Triano@frx.com Liesel.Enke@fleishman.com
Ticker Symbol: (NYSE:FRX),(NYSE:MYL)
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Posted: December 2007
- FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension - December 3, 2007
- Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol - May 1, 2007
- Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol - June 1, 2005
- FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005 - February 25, 2005
- Mylan's NDA for Nebivolol Accepted for FDA Review - July 1, 2004
- Mylan Submits New Drug Application for Nebivolol - May 5, 2004
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