LIVDELZI
NDA 217899 · New Drug Application (NDA) Prescription
SELADELPAR LYSINE
- Sponsor (Drugs@FDA)
- GILEAD SCIENCES INC Company: GILEAD SCIENCES, INC. (GILD)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | LIVDELZI SELADELPAR LYSINE | CAPSULE;ORAL EQ 10MG BASE | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 2 | Approved | standard | Labeling | Letter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
6 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 7301050Product 001 | Drug substance, Drug product | – | ||
| 7709682Product 001 | Drug substance | – | ||
| 9486428Product 001 | Method of use | U-1854 | ||
| 11406611Product 001 | Method of use | U-1854 | ||
| 11596614Product 001 | Method of use | U-1854 | ||
| 10272058Product 001 | Method of use | U-1854 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| ODE-486 | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
Livdelzi
SELADELPAR LYSINE · Gilead Sciences, Inc · ORAL · Version 3 · effective
Indications and usage
1 INDICATIONS AND USAGE 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 the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduct…
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 61958-3301 in openFDA (opens in a new tab) | Livdelzi SELADELPAR LYSINE | Gilead Sciences, Inc | CAPSULE ORAL | NDA | From |
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Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.