FDA declines to approve Bystolic as heart failure treatment
NEW YORK The Food and Drug Administration has declined to approve the use of a drug made by Forest Labs for heart failure, Forest announced Tuesday.
Forest said the agency did not approve its supplemental new drug application for Bystolic (nebivolol) tablets as a treatment for stable chronic heart failure. The drug already has approval as a treatment for hypertension.
Nevertheless, the FDA added information to the “Specific Populations” section of Bystolic’s product label about a placebo-controlled trial of 2,128 patients older than 70 years with chronic failure whose disease did not worsen while they took the drug, compared with those on placebo.
The company has said it will “continue to work closely” with the agency to discuss further steps.