Byvalson Approval History
Byvalson (nebivolol and valsartan) is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) fixed dose combination indicated for the treatment of hypertension.
The safety and efficacy of Byvalson was established from the results of a double-blind, placebo-controlled, phase 3 study of approximately 4,100 patients with Stage 1 or 2 hypertension. Data demonstrated statistically significant reductions in blood pressure in patients taking the fixed-dose combination of nebivolol/valsartan compared to those taking either nebivolol alone or valsartan alone.
Byvalson is a tablet taken orally once a day with or without food. The most common side effect of Byvalson is bradycardia (slow heartbeat).
Development History and FDA Approval Process for Byvalson
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