Active substance
Fludarabine
- SFDA 6
- US FDA 14
- Health Canada 3
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FLUDARA 10MG F.C TABLETS | 10 mg | Film-coated tablet · Oral use | 20 Blister | SAR 1986.40 | NCE · Prescription | Sanofi B.V | Valid |
| FLUDARA 50 mg injection | 50 mg | Powder for solution for injection/infusion · Intravenous use | 5 Vial | SAR 500.80 | Generic · Prescription | Sanofi B.V | Valid |
| Fludarabine Phosphate Neapolis | 25 mg/ml | Solution for injection/infusion · Intramuscular and intravenous use | 1 Vial | SAR 161.05 | Generic · Prescription | LES LABORATORIES NEAPOLIS PHARMA | Valid |
| FLUDARA 10MG F.C. TABLETS | 10 mg | Film-coated tablet · Oral use | 20 Blister | SAR 3334.80 | NCE · Prescription | BAYER SCHERING PHARMA | Withdrawn by regulatory authority · Not Marketed |
| FLUDARA 50MG I.V VIAL | 50 mg | Solution for injection · Intravenous use | 5 Vial | SAR 4767.55 | NCE · Prescription | BAXTER ONCOLOGY | Withdrawn by regulatory authority · Not Marketed |
| FLUDARABINE EBEWE 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION | 25 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 500.80 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); LYMPHOPLASMACYTIC LYMPHOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FLUDARABINE PHOSPHATE | 50MG/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 28 Aug 2003 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | SAGENT PHARMS INC | Prescription | 28 Apr 2004 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 15 Oct 2007 |
| FLUDARABINE PHOSPHATE | 50MG/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 15 Oct 2007 |
| FLUDARABINE PHOSPHATE | 50MG/VIAL | injectable · injection | ACTAVIS TOTOWA | Prescription | 11 Feb 2009 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | AREVA PHARMS | Prescription | 27 Sep 2010 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | HISUN PHARM HANGZHOU | Prescription | 23 Jul 2026 |
| FLUDARA | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | GENZYME CORP | Discontinued | 18 Apr 1991 |
| FLUDARABINE PHOSPHATE | 50MG/VIAL | injectable · injection | HOSPIRA | Discontinued | 6 Apr 2007 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | CAPLIN ONE LABS | Discontinued | 21 Sep 2007 |
| OFORTA | 10MG | tablet · oral | SANOFI AVENTIS US | Discontinued | 18 Dec 2008 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | PHARMAZONE | Discontinued | 21 Dec 2011 |
| FLUDARABINE PHOSPHATE | 50MG/VIAL | injectable · injection | RISING | Discontinued | 16 Oct 2012 |
| FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | injectable · injection | ACTAVIS LLC | Discontinued | 28 Feb 2017 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FLUDARA | 02246226 | 10 MG | TABLET · ORAL | SANOFI-AVENTIS CANADA INC |
| FLUDARABINE PHOSPHATE FOR INJECTION | 02283859 | 25 MG / ML | SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
| FLUDARABINE PHOSPHATE INJECTION, USP | 02438577 | 25 MG / ML | SOLUTION · INTRAVENOUS | ACCORD HEALTHCARE INC |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Chronic lymphocytic leukaemia or small lymphocytic lymphoma
Parenteral > General injections > IV: 50 mg in vial (fludarabine phosphate) powder for injection | Oral > Solid: 10 mg tablet (fludarabine phosphate)
Safety signals and safety-related labeling changes
- US FDA 19 Nov 2024 FLUDARABINE PHOSPHATE — 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.