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Obeticholic Acid News

FDA Medwatch Alert: Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

Posted 2 Feb 2018 by Drugs.com

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 (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for ...

FDA Medwatch Alert: Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

Posted 22 Sep 2017 by Drugs.com

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 increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also ...

Ocaliva Approved for Rare Liver Disease

Posted 15 Jun 2016 by Drugs.com

TUESDAY, May 31, 2016 – Ocaliva (obeticholic acid) has been approved by the U.S. Food and Drug Administration to treat a rare chronic liver disease called primary biliary cholangitis (PBC). The disease causes the liver's small bile ducts to become inflamed, ultimately destroying the ducts and leading to cirrhosis, which is scarring of the liver. Over time, this leads to a potentially deadly loss ...

FDA Grants Accelerated Approval to Ocaliva (obeticholic acid) for Primary Biliary Cholangitis

Posted 8 Jun 2016 by Drugs.com

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 non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary ...

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Biliary Cirrhosis

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Ocaliva

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