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Published on 24 February 2010

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FDA recommends Xifaxan for approval

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A Food and Drug Administration advisory panel has recommended Xifaxan be approved to treat brain damage caused by liver failure.

The news boosted shares in Xifaxan’s manufacturer Salix Pharmaceuticals by 17% to $28.60.

Shares in the firm had dropped nearly 14% as it had been halted from trading ahead of the outcome of the FDA’s panel.

The FDA’s gastrointestinal drugs panel voted 14 to 4 that the drug’s benefits warrant its approval. In a separate vote the panel also voted 14-4 in favour of the drug’s safety.

The FDA is not required to follow the group’s advice, though it usually does.

Xifaxan is already approved to treat diarrhoea. Salix has asked the FDA to approve the drug to treat hepatic encephalopathy, or neurological damage caused by liver failure. The problem occurs when the liver can no longer remove toxins from the blood, causing confusion, disorientation and possibly coma.

Copyright Press Association 2010
FDA



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