The U.S. Food and Drug Administration (FDA) has not granted approval of an additional indication for nebivolol (Bystolic™) tablets as a treatment for stable chronic heart failure (CHF).

However, the FDA has approved adding information to the Specific Populations section of the product label under “Heart Failure” stating that in a placebo-controlled trial of 2,128 patients (1,067 with nebivolol, 1,061 placebo) over 70 years of age with CHF, on which the submission was based, no worsening of heart failure was reported with nebivolol compared to placebo. If heart failure worsens physicians should consider discontinuation of nebivolol.

Editor’s note: In the UK, nebivolol (Sandoz, A.Menarini Pharma U.K, Winthrop Pharmaceuticals UK) is licensed for the treatment of essential hypertension and for the treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients > 70 years.