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February 27, 2014
08:03 EDTFRXForest Labs submits NDA for Nebivolol and Valsartan combination in hypertension
Forest Laboratories announced that it has submitted a New Drug Application to the Food and Drug Administration for a fixed dose combination 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. The single pivotal nebivolol/valsartan FDC trial was designed to meet the required regulatory “Combination Rule,” comparing the fixed dose combination against the highest approved doses of each component drug.
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