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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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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
2256 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.01————1
Plasma cell neoplasmsD054219——1————1
Indications Without Phase
No data
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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30,897 adverse events reported
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