What is Ocaliva, and what is it approved for?
Ocaliva (obeticholic acid) is approved for primary biliary cholangitis (PBC). The key label use is for adults with PBC who have had an inadequate response to ursodeoxycholic acid (UDCA) and/or cannot tolerate UDCA, including in combination with UDCA for those cases. [1]
Is Ocaliva approved for PBC alone, or are there other approved indications?
The provided approval information is specific to PBC (primary biliary cholangitis). No other indications are included in the cited approval details. [1]
When did Ocaliva get approved (and in which region)?
Ocaliva has regulatory approvals in multiple jurisdictions, but the specific approval timeline and region aren’t detailed in the provided source snippet. The cited source confirms that Ocaliva is approved for PBC. [1]
Who is the approval intended for (and who might not be eligible)?
The label use described is for adults with PBC with inadequate response to UDCA and/or UDCA intolerance. That implies the approval is aimed at people who do not respond sufficiently to UDCA or cannot take it. [1]
What patients often ask right after approval: what to watch for
Ocaliva carries important safety considerations and dosing constraints in practice, particularly around liver-related risk and use in people with more advanced disease. The provided source snippet confirms the PBC approval but does not list safety rules or contraindications, so those details aren’t included here. [1]
Where to check the exact label wording for your country
Because “approval” can differ by country (dose form, population wording, and whether it’s monotherapy vs add-on), the most reliable next step is to check the official label for your region (for example, the regulator’s product page or the prescribing information). The cited source points to product approval context for Ocaliva, but exact label text varies by jurisdiction. [1]
Sources
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204627