Quick answers
- What is Belinostat used for?
- The FDA-approved label (Beleodaq, Acrotech Biopharma Inc, April 7, 2025) says: “Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response […]. An improvement in survival or disease-related symptoms has not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Belinostat 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 Belinostat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Belinostat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Belinostat?
- 1 company lists prescription products of Belinostat in the FDA NDC Directory, including Acrotech Biopharma Inc.
What Belinostat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response […]. An improvement in survival or disease-related symptoms has not been established. …
— FDA label: Beleodaq, Acrotech Biopharma Inc, effective April 7, 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.
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 | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Beleodaq |
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.
- Acrotech Biopharma Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206256 BELEODAQ | Acrotech Biopharma | July 3, 2014 | 5, latest November 19, 2024 2024: Labeling · 2022: 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) | 1543547, 1543552 |
|---|---|
| SPL set ID of the quoted label | 2e8ef36b-71fa-4492-a16f-577d5f7d111d |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206256 |
| Active ingredients (FDA) | BELINOSTAT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Beleodaq, Acrotech Biopharma Inc, effective April 7, 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 →