FDA Warns Against Bystolic For Heart Patients

Law360, New York (January 7, 2010, 2:24 PM EST) -- Researchers at the U.S. Food and Drug Administration are urging the agency not to approve Forest Laboratories Inc.’s hypertension drug Bystolic for use with heart failure patients.

The agency’s advisory committee, which is set to discuss Bystolic in a meeting Monday, released background memos on Thursday cautioning against approving the drug for use in patients with heart failure.

“The totality of the evidence is not convincing to support a claim for treatment of heart failure,” FDA medical reviewer Shone Pendse said in documents prepared for the...
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