FDA staff is against approving Bystolic for heart failure

01/7/2010 | Reuters

FDA reviewers warned that a study on using Forest Laboratories' blood pressure drug Bystolic in heart failure patients underwent "several critical changes" that could have skewed the results. "The totality of evidence is not convincing to support a claim for treatment of heart failure" with Bystolic, said FDA staff, which issued the opinion ahead of a panel evaluation Monday.

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