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Ocaliva News
FDA Medwatch Alert: Drug Safety Communication: Ocaliva (obeticholic acid) - Serious Liver Injury Being Observed in Patients without Cirrhosis
ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. ...
FDA Medwatch Alert: FDA Restricts Use of Ocaliva (obeticholic acid) in Primary Biliary Cholangitis Patients with Advanced Cirrhosis Due to Risk of Serious Liver Injury
ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can ...
FDA Medwatch Alert: Drug Safety Communication: Ocaliva (obeticholic acid) - Boxed Warning Added To Highlight Correct Dosing
ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis...
FDA Medwatch Alert: Drug Safety Communication: Ocaliva (obeticholic acid) - Increased Risk of Serious Liver Injury
ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an...
FDA Grants Accelerated Approval to Ocaliva (obeticholic acid) for Primary Biliary Cholangitis
NEW YORK, May 27, 2016 (GLOBE NEWSWIRE) – Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat...