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Drug ReportsOfloxacin
Ofloxacin
Ocuflox, Ofloxacin (ofloxacin) is a small molecule pharmaceutical. Ofloxacin was first approved as Floxin on 1990-12-28. It is used to treat bacterial conjunctivitis, bacterial infections, bacterial skin diseases, bronchitis, and chlamydia infections amongst others in the USA.
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Target
Variants
Financial
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Safety
Events Timeline
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3M
6M
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2Y
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FDA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Ocuflox, Ofloxacin (discontinued: Floxin, Ofloxacin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ofloxacin
Tradename
Company
Number
Date
Products
OCUFLOXAllerganN-019921 RX1993-07-30
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ocufloxNew Drug Application2024-06-13
ofloxacinANDA2024-12-24
ofloxacin ophth solnANDA2023-05-22
ofloxacin ophthalmicANDA2022-10-28
ofloxacin oticANDA2024-12-26
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01M: Quinolone antibacterials
J01MA: Fluoroquinolone antibacterials, systemic
J01MA01: Ofloxacin
J01R: Combinations of antibacterials
J01RA: Combinations of antibacterials
J01RA09: Ofloxacin and ornidazole
S: Sensory organ drugs
S01: Ophthalmologicals
S01A: Antiinfective ophthalmologics
S01AE: Fluoroquinolone antiinfectives, ophthalmologic
S01AE01: Ofloxacin
S02: Otologicals
S02A: Antiinfective drugs, otologic
S02AA: Antiinfectives
S02AA16: Ofloxacin
HCPCS
Code
Description
J0200
Injection, alatrofloxacin mesylate, 100 mg
J0744
Injection, ciprofloxacin for intravenous infusion, 200 mg
J1956
Injection, levofloxacin, 250 mg
J7342
Instillation, ciprofloxacin otic suspension, 6 mg
S0034
Injection, ofloxacin, 400 mg
Clinical
Clinical Trials
418 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_000054458305030120
Communicable diseasesD0031411319201557
Helicobacter infectionsD016481EFO_10009614231340
TuberculosisD014376EFO_0000774A15-A19410175838
PneumoniaD011014EFO_000310661510231
Urinary tract infectionsD014552EFO_0003103N39.033107324
Multidrug-resistant tuberculosisD018088EFO_0007381683318
CataractD002386HP_0000518H26.94137217
Disease susceptibilityD004198210214
Healthy volunteers/patients813214
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute diseaseD0002082528
OtitisD0100312617
ProstatitisD011472EFO_0003830N411517
Hiv infectionsD015658EFO_0000764B202136
RhinosinusitisD00009682512316
Bacterial infectionsD001424A491326
FibrosisD0053552125
Cystic fibrosisD003550EFO_0000390E842125
Bacterial conjunctivitisD003234EFO_1000829H10.01325
BacteremiaD016470EFO_0003033R78.81145
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577112
Overactive urinary bladderD053201EFO_1000781N32.8111
Kidney diseasesD007674EFO_0003086N0811
Retinal diseasesD012164HP_0000479H35.911
Hearing lossD034381EFO_0004238H91.911
OtotoxicityD00008101511
DeafnessD003638EFO_0001063H91.911
Escherichia coli infectionsD004927EFO_1001318B96.2011
Sars-cov-2D00008640211
Short bowel syndromeD012778K90.8211
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805HP_0100806A41.955
Retinal detachmentD012163EFO_0005773H33.233
Wounds and injuriesD014947T14.833
EndometritisD004716EFO_100131233
Ischemic strokeD00008324233
StrokeD020521EFO_0000712I63.933
IschemiaD007511EFO_000055633
Cerebral infarctionD002544I6333
Prosthesis-related infectionsD016459EFO_100140622
Chemical and drug induced liver injuryD056486EFO_000422822
Show 61 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOfloxacin
INNofloxacin
Description
Ofloxacin is a racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. It has a role as a DNA synthesis inhibitor, an antiinfective agent, an antibacterial drug, an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor and a topoisomerase IV inhibitor. It is a quinolone antibiotic, a fluoroquinolone antibiotic and a racemate. It contains a levofloxacin and a dextrofloxacin.
Classification
Small molecule
Drug classantibacterials (quinolone derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Identifiers
PDB
CAS-ID82419-36-1
RxCUI
ChEMBL IDCHEMBL4
ChEBI ID7731
PubChem CID4583
DrugBankDB01165
UNII IDA4P49JAZ9H (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Ofloxacin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 19,180 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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98,158 adverse events reported
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