Fludarabine

Orphan Drug Cold Chain RequiredFDA Approved

Description

Fludarabine is a purine analog antimetabolite used in conditioning regimens for hematopoietic stem cell transplantation. It is utilized in the treatment of severe combined immunodeficiency and other primary immunodeficiency disorders requiring transplantation. The drug provides immunosuppression and myeloablation necessary for successful engraftment.

Indications & Therapeutic Use

Conditioning regimen for hematopoietic stem cell transplantation, chronic lymphocytic leukemia, severe combined immunodeficiency

Global Availability (6 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
Fludarabine
Generic NameFludarabine
Brands1 brand available
Active IngredientFludarabine phosphate
Drug ClassConditioning regimen for hematopoietic stem cell transplantation
ManufacturerGenzyme
Dosage FormsIV infusion, 25mg/mL; Oral tablet, 10mg
Medical CodeL01BB05
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Lead Time10 days
Reg. StatusFDA Approved
Clinical TrialNCT00002639
Countries6 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations7 Validated Nodes