Wider Use of Forest Drug Fails to Gain FDA Approval
Wider Use of Forest Drug Fails to Gain FDA Approval

On Thursday, the US Food and Drug Administration ruled that a Forest Laboratories Inc. drug for hypertension should not be approved for use in people with heart failure. The ruling came out as a part of the drug's preliminary analysis report.

According to the staff memo of the FDA, which was prepared for an agency advisory panel, "the totality of evidence is not convincing to support a claim for treatment of heart failure" with the drug, marketed as Bystolic.

As per FDA reviewer Shona Pendse, "Approval is not recommended for the heart failure use".

The drug is already being sold by Forest as a treatment for high blood pressure.

On Monday, at a public meeting, an FDA panel consisting of outside experts is now scheduled to review the data on the drug's use in heart failure patients, and before making any recommendations, the panel will hear from FDA reviewers and the manufacturing company itself.

When making any final decisions, the FDA usually follows the panel's advice.

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