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FDA Medication Tracker

← All approvals · Kidney, liver & lung · 2024

Livdelzi (seladelpar)

The FDA approved Livdelzi (seladelpar) on August 14, 2024 to treat primary biliary cholangitis (PBC).
Brand name
Livdelzi
Generic name
seladelpar
FDA approval date
August 14, 2024
Approved use (FDA wording)
To treat primary biliary cholangitis (PBC)
Company
Gilead Sciences Inc.
Application
NDA217899
Dosage form / route
CAPSULE · ORAL
Boxed warning on label
Not listed
Category on this site
Kidney, liver & lung

Indications and usage, from the FDA label

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). LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for th…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.