Quick answers
- What is Lusutrombopag used for?
- The FDA-approved label (Mulpleta, Vancocin Italia Srl, December 9, 2025) says: “MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. MULPLETA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lusutrombopag have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lusutrombopag?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lusutrombopag been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lusutrombopag?
- 3 companies list prescription products of Lusutrombopag in the FDA NDC Directory, including Eddingpharm (U. S. ) Inc., Shionogi Inc. and Vancocin Italia SRL.
What Lusutrombopag is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. MULPLETA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
— FDA label: Mulpleta, Vancocin Italia Srl, effective December 9, 2025. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Mulpleta |
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.
- Eddingpharm (U. S. ) Inc.1 product
- Shionogi Inc.1 product
- Vancocin Italia SRL1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210923 MULPLETA | Vancocin Italia | July 31, 2018 | — |
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) | 2054989, 2054995 |
|---|---|
| SPL set ID of the quoted label | a390aec3-6e77-45f8-95d3-d4b8c2eeee40 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA210923 |
| Active ingredients (FDA) | LUSUTROMBOPAG |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mulpleta, Vancocin Italia Srl, effective December 9, 2025; 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 →