Byvalson Approved for the Treatment of High Blood Pressure
June 3, 2016 – The U.S. Food and Drug Administration (FDA) approved Byvalson™ (nebivolol/valsartan), manufactured by Allergan. Byvalson is indicated for lowering high blood pressure. Tablets of Byvalson contain 5mg of a beta blocker (nebivolol) and 80mg of valsartan, an angiotensin II receptor blocker (ARB) and are to be taken once daily. Byvalson can be used either as first-line treatment or for patients whose high blood pressure is not managed adequately by taking either nebivolol or valsartan alone. It also may be taken along with drugs from other classes, such as diuretics. Labeling for Byvalson has a boxed warning against using it during pregnancy because the ARB component may cause fetal death or birth defects that could include bone, kidney or lung damage.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.