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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Levofloxacin (discontinued: Iquix, Levaquin, Levofloxacin, Quixin)
Drug Products
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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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Brand Name | Status | Last Update |
|---|---|---|
| levaquin | ANDA | 2020-11-23 |
| levofloxacin | ANDA | 2024-10-21 |
| ofloxacin | ANDA | 2024-04-29 |
| ofloxacin ophth soln | ANDA | 2023-05-22 |
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Agency Specific
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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
414 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 5 | 8 | 30 | 50 | 30 | 120 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 19 | 20 | 15 | 57 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 4 | 23 | 13 | 40 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 4 | 10 | 17 | 5 | 8 | 38 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 6 | 15 | 10 | 2 | 31 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 3 | 3 | 10 | 7 | 3 | 24 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 6 | 8 | 3 | 3 | 18 |
| Cataract | D002386 | HP_0000518 | H26.9 | 3 | 1 | 3 | 7 | 2 | 16 |
| Healthy volunteers/patients | — | — | — | 8 | 1 | — | 3 | 2 | 14 |
| Disease susceptibility | D004198 | — | — | — | — | 1 | 10 | 2 | 13 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | 2 | 5 | — | 2 | 8 |
| Otitis | D010031 | — | — | — | 2 | 6 | — | 1 | 7 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | 1 | 5 | — | 1 | 7 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | 1 | — | 3 | 6 |
| Rhinosinusitis | D000096825 | — | — | 1 | 2 | 3 | — | 1 | 6 |
| Bacterial infections | D001424 | — | A49 | 1 | — | 3 | — | 2 | 6 |
| Fibrosis | D005355 | — | — | 2 | 1 | 2 | — | — | 5 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 1 | 2 | — | — | 5 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | 1 | 3 | 2 | — | — | 5 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | 4 | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | 1 | — | — | 4 | 5 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | 2 | — | — | — | 3 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | — | 2 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Antibiotic prophylaxis | D019072 | — | — | — | 1 | — | — | — | 1 |
| Meningeal tuberculosis | D014390 | — | A17.0 | 1 | 1 | — | — | — | 1 |
| Pterygium | D011625 | — | H11.0 | 1 | 1 | — | — | — | 1 |
| Corneal diseases | D003316 | — | H18.9 | 1 | 1 | — | — | — | 1 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | — | — | — | — | 1 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | 1 | — | — | — | — | 1 |
| Ototoxicity | D000081015 | — | — | 1 | — | — | — | — | 1 |
| Deafness | D003638 | EFO_0001063 | H91.9 | 1 | — | — | — | — | 1 |
| Escherichia coli infections | D004927 | EFO_1001318 | B96.20 | 1 | — | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | — | — | 1 |
| Short bowel syndrome | D012778 | — | K90.82 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 5 | 5 |
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 3 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 3 | 3 |
| Endometritis | D004716 | EFO_1001312 | — | — | — | — | — | 3 | 3 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 3 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 3 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 3 | 3 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 3 | 3 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | — | — | — | — | 2 | 2 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 2 | 2 |
Show 62 more
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) |
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Black-box warning for: Levofloxacin
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123,943 adverse events reported
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