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Bystolic wins FDA approval for hypertension

Forest Laboratories and Mylan reveal that the novel beta-blocker Bystolic has won FDA approval for the treatment of hypertension in the US

US-based pharmaceutical companies Forest Laboratories and Mylan have revealed that the novel beta-blocker Bystolic (nebivolol) has won FDA approval for the treatment of hypertension in the US.

Bystolic 10 mg is a once daily medication for single use or in combination with other hypertension treatments. The drug decreases heart rate and myocardial contractility and suppresses renin activity.

Bystolic is approved and marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan in-licensed the US and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, in 2001.

Forest in-licensed US and Canadian rights to Bystolic from Mylan in January 2006.  The company will market Bystolic in the US and pay Mylan undisclosed royalty payments as part of the agreement.

Forest says Bystolic will be available on the US market in January 2008.

The FDA approval was based on a clinical trial 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 per cent African-Americans, 54 per cent male, 19 per cent elderly and eight per cent diabetic patients. 

Forest also co-promotes in the US the Daiichi Sankyo products Benicar (olmesartan), an angiotensin receptor blocker, Benicar HCT (olmesartan), an angiotensin receptor blocker and diuretic combination product, and Azor (amlodipine/ olmesartan) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.

19th December 2007

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