Saturday, July 11, 2026

Drug profile · INN

fludarabine

fludarabine (FLUDARA) is an FDA-listed pharmaceutical active ingredient. Associated with Sanofi-aventis Healthcare Pty Ltd.

TGA: approved NMPA: clinical trials
Patents linked 0
Pipeline programs 56
News articles 0
Drug details — fludarabine

Quick answer

fludarabine (FLUDARA) is an FDA-listed pharmaceutical active ingredient. Associated with Sanofi-aventis Healthcare Pty Ltd.

Key facts

INN fludarabine
Brand FLUDARA

Approval history

Authority Status Date
TGA approved
NMPA clinical trials

Pipeline programs

  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. 68284528MMY3002 Phase 3 · Janssen-Cilag International N.V · Relapsed and Lenalidomide-Refractory Multiple Myeloma
  3. 68284528MMY3004 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  4. ACE-CL-311 (AMPLIFY) Phase 3 · Anaxis Pharma · Previously untreated Chronic Lymphocytic Leukemia Without de
  5. ALL SCTped FORUM Phase 3 · George Institute for · Acute Lymphoblastic Leukaemia
  6. APG2575CC301 Phase 3 · Anaxis Pharma · Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocyt
  7. CA088-1007 Phase 3 · Celgene · Relapsed or Refractory and Lenalidomide exposed Multiple Mye
  8. CCTL019H2301 Phase 3 · Novartis India · Adult patients with relapsed or refractory aggressive B-cell

Frequently asked questions

What is fludarabine?

fludarabine (FLUDARA) is an FDA-listed pharmaceutical active ingredient. Associated with Sanofi-aventis Healthcare Pty Ltd.

What is the brand name for fludarabine?

FLUDARA is a marketed brand name for fludarabine. Check FDA Drugs@FDA for the current US label holder and prescribing information.