Quick answers
- What is Linerixibat used for?
- The FDA-approved label (Lynavoy, Intercept Pharmaceuticals Inc, July 29, 2026) says: “LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Linerixibat have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Linerixibat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Linerixibat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Linerixibat?
- 1 company lists prescription products of Linerixibat in the FDA NDC Directory, including Intercept Pharmaceuticals Inc.
What Linerixibat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) […]. …
— FDA label: Lynavoy, Intercept Pharmaceuticals Inc, effective July 29, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Lynavoy |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Intercept Pharmaceuticals Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA220295 LYNAVOY | Intercept | March 17, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2745144, 2745150 |
|---|---|
| SPL set ID of the quoted label | c00317c8-709c-4707-a6d1-632bff123026 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA220295 |
| Active ingredients (FDA) | LINERIXIBAT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lynavoy, Intercept Pharmaceuticals Inc, effective July 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →