Prescription medicine
Romidepsin Brand names: Istodax
Romidepsin (Istodax) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the romidepsin FDA label on DailyMed (effective January 31, 2023, Celgene Corporation); the NDA 22393 record on Drugs@FDA; every romidepsin label on DailyMed.
Highlights of the record
FDA label of January 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
Forms and strengths
- 5 mg/ml
Kit; injection (solution) (concentrate).
On the market
- Earliest approval on file
- November 5, 2009 Istodax, Bristol-Myers; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first October 12, 2021; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,666 through July 30, 2026
What is romidepsin used for?
From the label: indications and usageISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
Conditions named in the indications of romidepsin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histone Deacetylase Inhibitor.
Source: FDA drug label (ISTODAX), NDA022393 (Bristol-Myers), as published by Celgene Corporation, effective January 31, 2023 (SPL set 03b39d40-90fe-11df-9de6-0002a5d5c51b), via openFDA; the full label on DailyMed
Is there a generic for romidepsin (Istodax)?
The FDA approved the first generic romidepsin on October 12, 2021. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists romidepsin from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2009 earliest approval on file
- 2021 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the romidepsin label say about other medicines?
The romidepsin label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ganciclovir | warnings and precautions | Reactivation of Epstein Barr viral infection leading to liver failure has occurred in recipients of ISTODAX including after ganciclovir prophylaxis. |
| Rifampin | drug interactions | Avoid use with rifampin and strong CYP3A4 inducers ( 7.3 ). |
| Warfarin | drug interactions | Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and warfarin or coumarin derivatives ( 7.1 ). |
Source: FDA drug label (ISTODAX), NDA022393 (Bristol-Myers), as published by Celgene Corporation, effective January 31, 2023 (SPL set 03b39d40-90fe-11df-9de6-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show for romidepsin?
The FDA Adverse Event Reporting System holds 1,666 reports that list romidepsin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 444 are coded as a death and 564 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as romidepsin?
36 other medicines are given the same way (intravenous) and in the same FDA class as romidepsin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Belinostat | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as romidepsin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to romidepsin
- 36 medicines for the same use
- Other histone deacetylase inhibitors
- the pharmacologic class, with prices and generics
- Romidepsin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other