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Byvalson FDA Approval History

Last updated by Judith Stewart, BPharm on June 10, 2020.

FDA Approved: Yes (Discontinued) (First approved June 3, 2016)
Brand name: Byvalson
Generic name: nebivolol and valsartan
Dosage form: Tablets
Company: Forest Laboratories, LLC
Treatment for: High Blood Pressure

Marketing Status: Discontinued

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 timeline for Byvalson

Jun  7, 2016Approval Allergan Announces FDA Approval of Byvalson (nebivolol and valsartan) for Hypertension
Dec 24, 2014Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension
Feb 27, 2014Forest Laboratories Submits NDA for Nebivolol and Valsartan Combination in Hypertension

Further information

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