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Fetroja, Fetcroja(cefiderocol)
Fetcroja, Fetroja (cefiderocol) is a small molecule pharmaceutical. Cefiderocol was first approved as Fetroja on 2019-11-14. It is used to treat bacterial infections, pyelonephritis, and urinary tract infections in the USA. It has been approved in Europe to treat gram-negative bacterial infections.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Fetroja
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cefiderocol sulfate tosylate
Tradename
Company
Number
Date
Products
FETROJAShionogiN-209445 RX2019-11-14
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fetrojaNew Drug Application2020-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infectionsD001424A49
pyelonephritisEFO_1001141D011704N10-N16
urinary tract infectionsEFO_0003103D014552N39.0
Agency Specific
FDA
EMA
Expiration
Code
CEFIDEROCOL SULFATE TOSYLATE, FETROJA, SHIONOGI INC
2029-11-14GAIN
2024-11-14NCE
2023-09-25I-844
Patent Expiration
Patent
Expires
Flag
FDA Information
Cefiderocol Sulfate Tosylate, Fetroja, Shionogi Inc
99499822035-09-03DP
100047502035-09-03DS, DP
92386572033-11-14DS, DPU-282, U-3470, U-3471
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01D: Other beta-lactam antibacterials in atc
J01DI: Other cephalosporins and penems in atc
J01DI04: Cefiderocol
HCPCS
Code
Description
J0699
Injection, cefiderocol, 10 mg
Clinical
Clinical Trials
14 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial pneumoniaD018410EFO_1001272J15.9112
Cystic fibrosisD003550EFO_0000390E8411
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805A41.91214
Urinary tract infectionsD014552EFO_0003103N39.0314
Healthcare-associated pneumoniaD000077299224
Ventilator-associated pneumoniaD053717EFO_1001865J95.851123
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-negative bacterial infectionsD01690522
Intraabdominal infectionsD05941311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
PharmacokineticsD01059911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424A4911
Respiratory distress syndromeD012128EFO_1000637J8011
Cross infectionD00342811
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCEFIDEROCOL
INNcefiderocol
Description
Cefiderocol, sold under the brand name Fetroja among others, is an antibiotic used to treat complicated urinary tract infections when no other options are available. It is indicated for the treatment of multi-drug-resistant Gram-negative bacteria including Pseudomonas aeruginosa. It is given by injection into a vein.
Classification
Small molecule
Drug classcephalosporins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)(O/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[N+]3(CCNC(=O)c4ccc(O)c(O)c4Cl)CCCC3)CS[C@H]12)c1csc(N)n1)C(=O)O
Identifiers
PDB
CAS-ID1225208-94-5
RxCUI2265702
ChEMBL IDCHEMBL3989974
ChEBI ID
PubChem CID77843966
DrugBankDB14879
UNII IDSZ34OMG6E8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,317 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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