27.02.2014 14:07:08

Forest Labs Submits NDA For Nebivolol And Valsartan Combination In Hypertension

(RTTNews) - Forest Laboratories Inc. (FRX) announced that it has submitted a New Drug Application or NDA to the Food and Drug Administration or FDA for a fixed dose combination or 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.

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