Istodax Celgene Europe Ltd. · Refused · ATC L01XX39
Therapeutic indication (EMA)
treatment of peripheral T-cell lymphoma (PTCL)
Active substance
Romidepsin
- US FDA 4
- EMA 1
- Health Canada 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ISTODAX | 10MG/VIAL | powder · intravenous | BRISTOL-MYERS | Prescription | 5 Nov 2009 |
| ROMIDEPSIN | 10MG/VIAL | powder · intravenous | FRESENIUS KABI USA | Prescription | 12 Oct 2021 |
| ROMIDEPSIN | 27.5MG/5.5ML (5MG/ML) | solution · intravenous | AMNEAL | Prescription | 2 Jun 2026 |
| ROMIDEPSIN | 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intravenous | TEVA PHARMS USA INC | Discontinued | 13 Mar 2020 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ISTODAX | 02414295 | 10 MG / VIAL | POWDER FOR SOLUTION; KIT · INTRAVENOUS | BRISTOL-MYERS SQUIBB CANADA |
Safety signals and safety-related labeling changes
- US FDA 8 Dec 2021 ROMIDEPSIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 30 Jul 2021 ISTODAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.