Levaquin, Quinsair(levofloxacin)
Iquix, Levaquin, Quinsair, Quixin (levofloxacin) is a small molecule pharmaceutical. Levofloxacin was first approved as Levaquin on 1996-12-20. It is used to treat bacterial eye infections, bacterial infections, bacterial pneumonia, bacterial skin diseases, and bronchitis amongst others in the USA. It has been approved in Europe to treat cystic fibrosis and respiratory tract infections.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Levofloxacin (discontinued: Iquix, Levaquin, Levofloxacin, Quixin)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levofloxacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LEVAQUIN | Johnson & Johnson | N-020634 DISCN | 1996-12-20 | 3 products, RLD |
| LEVAQUIN | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 2 products, RLD |
| LEVAQUIN | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
| LEVAQUIN | Johnson & Johnson | N-021721 DISCN | 2004-10-21 | 1 products, RLD |
| IQUIX | Santen | N-021571 DISCN | 2004-03-01 | 1 products, RLD |
| QUIXIN | Santen | N-021199 DISCN | 2000-08-18 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| levaquin | ANDA | 2020-11-23 |
| levofloxacin | ANDA | 2025-02-11 |
| ofloxacin | ANDA | 2025-02-05 |
| ofloxacin ophth soln | ANDA | 2025-01-22 |
Indications
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Agency Specific
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Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA12: Levofloxacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA05: Levofloxacin and ornidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AE: Fluoroquinolone antiinfectives, ophthalmologic
— S01AE05: Levofloxacin
HCPCS
Code | Description |
|---|---|
| J1956 | Injection, levofloxacin, 250 mg |
Clinical
Clinical Trials
421 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | 2 | 1 | — | 3 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | 1 | — | 1 |
| Critical illness | D016638 | — | — | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | 6 | — | — | 6 |
| Communicable diseases | D003141 | — | — | — | 1 | 5 | — | — | 5 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 3 | — | 1 | 4 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 3 | — | 1 | 4 |
| Bronchitis | D001991 | — | J40 | — | 1 | 3 | — | 1 | 4 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 4 | — | — | 4 |
| Chronic bronchitis | D029481 | — | J42 | — | 1 | 3 | — | — | 3 |
| Acute disease | D000208 | — | — | — | 1 | 3 | — | — | 3 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | 3 | — | — | 3 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | — | 2 | — | — | 2 |
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 2 | 2 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
| Dissociative disorders | D004213 | — | F44.1 | — | — | — | — | 1 | 1 |
| Musculoskeletal diseases | D009140 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levofloxacin |
| INN | levofloxacin |
| Description | Levofloxacin is an optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase. It has a role as a DNA synthesis inhibitor, an antibacterial drug, a topoisomerase IV inhibitor and an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor. It is a quinolone antibiotic, a fluoroquinolone antibiotic and a 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid. It is an enantiomer of a dextrofloxacin. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H]1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23 |
Identifiers
| PDB | — |
| CAS-ID | 100986-85-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL33 |
| ChEBI ID | 63598 |
| PubChem CID | 149096 |
| DrugBank | DB01137 |
| UNII ID | RIX4E89Y14 (ChemIDplus, GSRS) |
Target
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Quinsair – Horizon Therapeutics Public
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Estimated US medical usage
Levofloxacin
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Trends
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Safety
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129,075 adverse events reported
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