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AboutPricing
Drug ReportsFludarabine
Fludarabine phosphate
Fludara, Oforta (fludarabine phosphate) is a small molecule pharmaceutical. Fludarabine phosphate was first approved as Fludara on 1991-04-18. It is used to treat b-cell chronic lymphocytic leukemia and non-hodgkin lymphoma in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fludarabine phosphate
Tradename
Company
Number
Date
Products
FLUDARASanofiN-020038 DISCN1991-04-18
1 products, RLD
FLUDARABINE PHOSPHATESandozN-022137 DISCN2007-09-21
1 products, RLD
OFORTASanofiN-022273 DISCN2008-12-18
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
fludarabineANDA2019-12-31
fludarabine phosphateunapproved drug for use in drug shortage2023-07-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell chronic lymphocytic leukemia—D015451C91.1
non-hodgkin lymphoma—D008228C85.9
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BB: Purine analogs, antimetabolites antineoplastic
— L01BB05: Fludarabine
HCPCS
Code
Description
J8562
Fludarabine phosphate, oral, 10 mg
J9185
Injection, fludarabine phosphate, 50 mg
Clinical
Clinical Trials
2072 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470—C92.014121047523365
Myelodysplastic syndromesD009190—D4610922120225332
LeukemiaD007938—C958716620223255
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.010314616518249
B-cell chronic lymphocytic leukemiaD015451—C91.18114225312232
Non-hodgkin lymphomaD008228—C85.9991219117209
LymphomaD008223—C85.9631048119173
Myeloproliferative disordersD009196—D47.1153231751
Graft vs host diseaseD006086—D89.81143021242
Beta-thalassemiaD017086Orphanet_848D56.125—219
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.0841009—17186
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—26895—11116
Hodgkin diseaseD006689—C8136733—13109
NeoplasmsD009369—C8067381—590
MelanomaD008545——46561—288
Hematologic neoplasmsD019337——31571—1386
Follicular lymphomaD008224—C8232459—582
Mantle-cell lymphomaD020522—C83.135447—578
Large b-cell lymphoma diffuseD016403—C83.341393—473
Aplastic anemiaD000741HP_0001915D61.910374—1152
Show 31 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——4319——360
Plasma cell neoplasmsD054219——1430——646
Ovarian neoplasmsD010051EFO_0003893C562921———39
Breast neoplasmsD001943EFO_0003869C502020———31
Biphenotypic leukemia acuteD015456—C95.01518———30
B-cell lymphoma marginal zoneD018442—C88.41017——529
Myelomonocytic leukemia juvenileD054429—C93.3717——324
NeuroblastomaD009447EFO_0000621—1610———23
Kidney neoplasmsD007680EFO_0003865C641017——223
Renal cell carcinomaD002292EFO_0000376—1810——122
Show 197 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD064129——5————5
CarcinomaD002277—C80.04————4
Ovarian epithelial carcinomaD000077216——4————4
Wilms tumorD009396EFO_0000212—3————3
Squamous cell carcinoma of head and neckD000077195——3————3
Small cell lung carcinomaD055752——2————2
EpendymomaD004806——2————2
Primitive neuroectodermal tumorsD018242——2————2
Rhabdoid tumorD018335——2————2
Lymphatic diseasesD008206HP_0100763—2————2
Show 36 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PlasmacytomaD010954—C90.3————22
Aids-related lymphomaD016483EFO_1001365—————11
Chronic kidney failureD007676EFO_0003884N18.6————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFludarabine phosphate
INNfludarabine
Description
(2R,3S,4S,5R)-2-(6-amino-2-fluoro-9-purinyl)-5-(hydroxymethyl)oxolane-3,4-diol is a purine nucleoside.
Classification
Small molecule
Drug classantineoplastics (arabinofuranosyl derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)O)[C@@H](O)[C@@H]1O
Identifiers
PDB—
CAS-ID75607-67-9
RxCUI—
ChEMBL IDCHEMBL1096882
ChEBI ID63599
PubChem CID657237
DrugBankDB01073
UNII IDP2K93U8740 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 658 documents
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Safety
Black-box Warning
Black-box warning for: Fludarabine
Adverse Events
Top Adverse Reactions
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23,849 adverse events reported
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