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AboutPricing
Drug ReportsFludarabine
Fludarabine phosphate
Fludarabine (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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EMA approval date
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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
Fludarabine (discontinued: Fludara, Fludarabine, Oforta)
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
fludarabineANDA2024-10-14
fludarabine phosphateunapproved drug for use in drug shortage2023-07-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-hodgkin lymphoma—D008228C85.9
b-cell chronic lymphocytic leukemia—D015451C91.1
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
2483 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95313423801350739
Myeloid leukemia acuteD015470—C92.019527659629484
LymphomaD008223—C85.924525725336475
Myelodysplastic syndromesD009190—D4613027026230400
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.017820518527367
B-cell chronic lymphocytic leukemiaD015451—C91.112419237319326
Non-hodgkin lymphomaD008228—C85.916416714123306
Multiple myelomaD009101—C90.013114311128280
Lymphoid leukemiaD007945—C9112814732714276
Myeloid leukemiaD007951—C9210015434314257
Show 17 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801761124—17257
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—341146—11146
Hodgkin diseaseD006689—C8153953—16144
Follicular lymphomaD008224—C82496814—8125
Mantle-cell lymphomaD020522—C83.149659—9115
MelanomaD008545——58641—2106
AnemiaD000740EFO_0004272D64.922529—1074
Aplastic anemiaD000741—D61.914476—1671
Myelomonocytic leukemia chronicD015477—C93.125462—768
B-cell lymphoma marginal zoneD018442—C88.426362—867
Show 53 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C564723———57
T-cell lymphomaD016399——2633——353
CarcinomaD002277—C80.04017——350
Systemic lupus erythematosusD008180EFO_0002690M324211——246
Breast neoplasmsD001943EFO_0003869C503424———45
Renal cell carcinomaD002292EFO_0000376—2921——343
Myeloid leukemia accelerated phaseD015465——932——541
PlasmacytomaD010954—C90.31322——638
Non-small-cell lung carcinomaD002289——3014———37
Hematologic diseasesD006402EFO_0005803D75.9725——737
Show 283 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rhabdoid tumorD018335——6————6
Autoimmune diseases of the nervous systemD020274——6————6
Small cell lung carcinomaD055752——4————4
Wilms tumorD009396EFO_0000212—4————4
Female genital neoplasmsD005833——4————4
MedulloblastomaD008527——3————3
EpendymomaD004806——3————3
Nervous system diseasesD009422—G00-G993————3
Kidney diseasesD007674EFO_0003086N083————3
Alveolar soft part sarcomaD018234——3————3
Show 65 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Abnormal karyotypeD059786——————11
Hemoglobin c diseaseD006445—D58.2————11
MucositisD052016EFO_1001898—————11
Hereditary congenital and neonatal diseases and abnormalitiesD009358——————11
Monoclonal gammopathy of undetermined significanceD008998EFO_1000836D47.2————11
Primary graft dysfunctionD055031——————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)
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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
No data
Safety
Black-box Warning
Black-box warning for: Fludarabine
Adverse Events
Top Adverse Reactions
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35,061 adverse events reported
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