The US Food and Drug Administration is once again warning about an increased risk of serious liver injury with Intercept’s primary biliary cholangitis treatment Ocaliva (obeticholic acid) in a safety alert that could herald the accelerated approval drug’s withdrawal.
Could Another US FDA Safety Alert Foreshadow Withdrawal Of Intercept’s Ocaliva?
The FDA's view that current monitoring recommendations may not be sufficient to mitigate harm increases the likelihood it could seek withdrawal.
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