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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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Target
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YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post 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
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
2325 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95405547991660951
LymphomaD008223C85.928131836341578
Myeloid leukemia acuteD015470C92.017824857626443
Myeloid leukemiaD007951C9216724446524413
Lymphoid leukemiaD007945C9117821742722395
Myelodysplastic syndromesD009190D4612526025229386
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.017519219524351
B-cell chronic lymphocytic leukemiaD015451C91.111918136315306
Non-hodgkin lymphomaD008228C85.915816316121298
Multiple myelomaD009101C90.012513911126268
Show 13 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80188144516297
Hematologic neoplasmsD01933778117419187
Plasma cell neoplasmsD0542199377916175
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034032111711141
Hodgkin diseaseD006689C814683313125
MelanomaD008545586422107
Follicular lymphomaD008224C82385512599
Mantle-cell lymphomaD020522C83.141549694
AnemiaD000740EFO_0004272D64.92662101288
Myelomonocytic leukemia juvenileD054429C93.328501672
Show 47 more
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rhabdoid tumorD01833544
Female genital neoplasmsD00583344
Small cell lung carcinomaD05575233
Wilms tumorD009396EFO_000021233
Nervous system diseasesD009422G00-G9933
Autoimmune diseases of the nervous systemD02027433
Kidney diseasesD007674EFO_0003086N0833
Chronic progressive multiple sclerosisD020528EFO_000384033
EpendymomaD00480622
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A22
Show 58 more
Indications Without Phase
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
No data
Safety
Black-box Warning
Black-box warning for: Fludarabine
Adverse Events
Top Adverse Reactions
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31,919 adverse events reported
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