Forest files combination nebivolol+ valsartan at FDA for Hypertension

Forest Laboratories, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for a fixed dose combination (FDC) of nebivolol and valsartan for the treatment of Hypertension. The application for the treatment of Hypertension includes results from an 8-week randomized, double-blind, placebo-controlled pivotal clinical trial in 4,161 hypertensive patients which studied different fixed combinations of nebivolol 5, 10, and 20 mg with valsartan 80, 160, and 320 mg versus placebo and compared to the individual drugs alone. It also includes the results from a 52-week, open-label study which assessed long-term safety/tolerability of the free tablet combination of nebivolol and valsartan in 807 patients.