Quick answers
- What is Ivosidenib used for?
- The FDA-approved label (Tibsovo, Servier Pharmaceutical LLC, December 22, 2025) says: “TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ivosidenib have a boxed warning?
- Yes. The FDA label for Tibsovo has a boxed warning (“WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ivosidenib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ivosidenib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ivosidenib?
- 1 company lists prescription products of Ivosidenib in the FDA NDC Directory, including Servier Pharmaceutical LLC.
What Ivosidenib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. …
— FDA label: Tibsovo, Servier Pharmaceutical LLC, effective December 22, 2025. 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tibsovo |
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.
- Servier Pharmaceutical LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211192 TIBSOVO | Servier | July 20, 2018 | 6, latest October 24, 2023 2023: Efficacy · 2022: Efficacy · 2021: Efficacy |
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) | 2049878, 2049884 |
|---|---|
| SPL set ID of the quoted label | 65d254c0-67ad-42c4-b972-ad463b755b2d |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211192 |
| Active ingredients (FDA) | IVOSIDENIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tibsovo, Servier Pharmaceutical LLC, effective December 22, 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 →