FDA Staff Against Wider Approval of Forest Drug

Lisa Richwine, Reuters

The Food and Drug Administration staff memo, prepared for an agency advisory panel, said "the totality of evidence is not convincing to support a claim for treatment of heart failure" with the drug, Bystolic.

"Approval is not recommended" for the heart failure use, FDA reviewer Shona Pendse wrote, adding that "several critical changes" were made to the main study "that raise concerns as to the interpretability of findings."

Safety data "does not reveal any specific causes for concern," Pendse said.

Forest shares fell nearly 0.7 percent to $31.70 in early morning trading on the New York Stock Exchange.

Forest launched Bystolic in 2008 for treating high blood pressure. The drug's second-quarter 2010 sales were $40.7 million.

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