The FDA has approved Byvalson (nebivolol and valsartan) fixed-dose combination of a beta blocker and angiotensin II receptor blocker for the treatment of hypertension.

Indication: Byvalson is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with other antihypertensive agents.

Dosage and administration: As initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose is 5 mg/80 mg taken orally once daily. Maximum antihypertensive effects are attained within 2 to 4 weeks. Byvalson may be substituted for its components in patients already receiving 5 mg nebivolol and 80 mg valsartan.

Adverse reactions: No adverse reactions were observed more frequently on Byvalson than on placebo.

Citation: Allergan announces FDA approval of BYVALSON™ (nebivolol and valsartan). [news release]. Dublin, Ireland: Allergan; June 6, 2016: http://phx.corporate-ir.net/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=2175228. Accessed June 13, 2016.