Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Conversis

Conversis is a translation company specialising in translation and localisation for the Life Science and Pharmaceutical industry, with particular focus...

Latest intelligence

Beyond the event
...
Anthill Agency and Actando partnership to Transform Pharma's Digital Skills
Anthill Agency, a leading life sciences digital agency, today announced the launch of the Anthill Academy™ and partnership with Actando's PharmAcademy....
Is the pharma business model ready for precision medicine?
Precision medicine promises to revolutionise patient outcomes and reduce costs for industry but is pharma ready for it? Blue Latitude Health co-founder Head of Strategy Fred Bassett explores the challenges...

Infographics