Quick answers
- What is Enasidenib mesylate used for?
- The FDA-approved label (Idhifa, Celgene Corporation, January 16, 2025) says: “IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Enasidenib mesylate have a boxed warning?
- Yes. The FDA label for Idhifa has a boxed warning (“WARNING: DIFFERENTIATION SYNDROME”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Enasidenib mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Enasidenib mesylate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Enasidenib mesylate?
- 1 company lists prescription products of Enasidenib mesylate in the FDA NDC Directory, including Celgene Corporation.
What Enasidenib mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. …
— FDA label: Idhifa, Celgene Corporation, effective January 16, 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
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Idhifa |
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.
- Celgene Corporation2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209606 IDHIFA | Bristol Myers Squibb | August 1, 2017 | 6, latest January 16, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
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) | 1940370, 1940372, 1940374, 1940376 |
|---|---|
| SPL set ID of the quoted label | a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA209606 |
| Active ingredients (FDA) | ENASIDENIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Idhifa, Celgene Corporation, effective January 16, 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 →