Emerging Ocaliva Litigation
Ocaliva (obeticholic acid) made by Intercept Pharmaceuticals, Inc. was first approved by the FDA subsequent to New Drug Application (NDA: 207999) in May 2016.
Ocaliva is “indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.
Recent FDA Communications Excerpts:
September 21, 2017, The FDA is notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid). This information pertains to the risk of liver injury, liver decompensation, liver failure and death in primary biliary cholangitis (PBC) patients withmoderate to severe hepatic impairment.
Additionally, we refer to our letter dated October 26, and December 7, 2017, notifying you, under Section 505(o)(4) of the FDCA, extension of discussion period warranted for new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid) Tablets. This information pertains to the risks liver injury, liver decompensation, liver failure and possibly death in primary biliary cholangitis (PBC) patients with moderate to severe hepatic impairment.
FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease: (see link below)
FDA Warning of September 21, 2017: https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm
>To Learn More About the Emerging Ocaliva Litigation:
The emerging Ocaliva Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at email@example.com or call (954) 520-4494.
For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”
Course attendees will receive the benefit of a step by step analysis of the emerging Ocaliva Litigaton, using these primary metrics:
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