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The Food and Drug Administration is evaluating a potential risk of liver injury in patients who take the Intercept Pharmaceuticals drug Ocaliva to treat a certain type of liver disease.

The FDA’s inquiry into Ocaliva began in May and could take one year to complete, Intercept spokesperson Christopher Frates told STAT. Intercept is cooperating with the FDA’s safety regulators, and “based on our work to date, we remain confident in the positive benefit-risk profile of Ocaliva when used as directed,” Frates said.

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