Ocaliva® (obeticholic acid) – New boxed warning
February 1, 2018 - The FDA announced the addition of a new Boxed Warning to the Ocaliva (obeticholic acid) drug label regarding hepatic decompensation and failure in incorrectly dosed primary biliary cholangitis (PBC) patients with Child-Pugh Class B or C decompensated cirrhosis.
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