Byvalson Approval History
- FDA approved: Yes (First approved June 3rd, 2016)
- Brand name: Byvalson
- Generic name: nebivolol and valsartan
- Dosage form: Tablets
- Company: Forest Laboratories, LLC
- Treatment for: High Blood Pressure
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
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.