FLUDARABINE PHOSPHATE

Post-LOE

fludarabine phosphate

Sagent Pharmaceuticals

ANDAINJECTIONINJECTABLE

Approved

Oct 2012

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FLUDARABINE PHOSPHATE (fludarabine phosphate) by Sagent Pharmaceuticals is 2-fluoro-ara-a and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-atp. Approved for whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. First approved in 2012.

Drug data last refreshed 19h ago

Mechanism of Action

2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this…

Indications (1)

whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen

Clinical Trials (4)

NCT03754933Phase 1/2Completed

Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer

Started Feb 2019

10 enrolled

Recurrent Head and Neck Cancer

NCT01163357Phase 1Completed

Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma

Started Jan 2011

NCT00185445Phase 2Completed

Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

Started Jun 2004

62 enrolled

Non Hodgkin Lymphoma

NCT00220311Phase 4Completed

A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

Started Nov 2000

10 enrolled

Leukemia, Lymphocytic, Chronic, B-Cell

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.