Quick answers
- What is Cedazuridine and decitabine used for?
- The FDA-approved label (Inqovi, Taiho Pharmaceutical Co., Ltd., May 25, 2026) says: “INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cedazuridine and decitabine 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 Cedazuridine and decitabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cedazuridine and decitabine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cedazuridine and decitabine?
- 1 company lists prescription products of Cedazuridine and decitabine in the FDA NDC Directory, including Taiho Pharmaceutical Co., Ltd..
What Cedazuridine and decitabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess …
— FDA label: Inqovi, Taiho Pharmaceutical Co., Ltd., effective May 25, 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.
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.
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 | Inqovi |
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.
- Taiho Pharmaceutical Co., Ltd.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212576 INQOVI | Taiho Oncology | July 7, 2020 | 2, latest May 13, 2026 2026: Efficacy · 2022: 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) | 2384457, 2384458, 2384464, 2384465 |
|---|---|
| SPL set ID of the quoted label | 91a0f80b-f865-4d06-a40d-4d148d99ee71 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA212576 |
| Active ingredients (FDA) | CEDAZURIDINE / DECITABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Inqovi, Taiho Pharmaceutical Co., Ltd., effective May 25, 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 →