Quick answers
- What is Glasdegib used for?
- The FDA-approved label (Daurismo, Pfizer Laboratories Div Pfizer Inc, December 12, 2025) says: “DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old 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 Glasdegib have a boxed warning?
- Yes. The FDA label for Daurismo has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Glasdegib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Glasdegib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Glasdegib?
- 1 company lists prescription products of Glasdegib in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc.
What Glasdegib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. …
— FDA label: Daurismo, Pfizer Laboratories Div Pfizer Inc, effective December 12, 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. 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 | Daurismo |
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.
- Pfizer Laboratories Div Pfizer Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210656 DAURISMO | Pfizer | November 21, 2018 | 3, latest March 27, 2023 2023: Labeling · 2020: Labeling · 2020: 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) | 2105850, 2105856, 2105858, 2105860 |
|---|---|
| SPL set ID of the quoted label | 204a6f7e-c9a4-472b-abd2-9527bda64d17 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA210656 |
| Active ingredients (FDA) | GLASDEGIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Daurismo, Pfizer Laboratories Div Pfizer Inc, effective December 12, 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 →