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These highlights do not include all the information needed to use LIVDELZI safely and effectively. See full prescribing information for LIVDELZI. LIVDELZI® (seladelpar) capsules, for oral use Initial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14)]. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy) [see Use in Specific Populations (8.7)].
- generic_name
- seladelpar lysine
- product_names
- SELADELPAR LYSINE
- ndc
- 61958-3301, 61958-3301-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en