NDAINJECTIONINJECTABLE
Approved
Sep 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
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. First approved in 2007.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fludarabine phosphate is a purine antimetabolite that inhibits DNA synthesis by blocking DNA polymerase alpha, ribonucleotide reductase, and DNA primase. It is an intravenous injectable used primarily in hematologic malignancies, particularly chronic lymphocytic leukemia and non-Hodgkin's lymphoma. The drug's multifaceted mechanism allows it to interfere with nucleotide metabolism and DNA replication in rapidly dividing cells.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure; commercial teams should expect transition planning and cost management focus rather than growth initiatives.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
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
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
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
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.