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In FDA Panel, 12 vote to withdraw Avandia

The New York Times live blogged the FDA Panel on Avandia.

3:37 p.m. The Vote on Removing Avandia

Twelve members voted to withdraw Avandia from the market, while 10 voted that it should continue to be sold but with serious revisions to its label as well as possible restrictions on its sale. Seven voted to simply add further warnings to the drug’s label. Three voted to allow further sales without change.

The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added.

A final decision will be made by the F.D.A., of course, at a later date.

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