BioCentury
ARTICLE | Clinical News

Nebivolol/valsartan regulatory update

March 3, 2014 8:00 AM UTC

Forest submitted an NDA to FDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Forest said the application was based on a double-blind pivotal trial in 4,161 hypertensive patients that compared fixed combinations of 5, 10 and 20 mg nebivolol with 80, 160 and 320 mg valsartan vs. placebo and compared to the individual drugs alone. ...