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Noroxin (NORFLOXACIN)
Noroxin (Norfloxacin) is a quinolone antimicrobial drug developed by Merck, targeting the gamma-aminobutyric acid receptor subunit alpha-1. It is a small molecule modality, approved by the FDA in 1986 for various bacterial infections, including abdominal abscess, acute bacterial bronchitis, and gonococcal cervicitis. Noroxin is off-patent, with no active Orange Book patents, and is not currently manufactured generically. The drug has a half-life of 4.45 hours and bioavailability of 35%. Key safety considerations include its potential to cause tendonitis and neuropathy.
At a glance
| Generic name | NORFLOXACIN |
|---|---|
| Sponsor | Merck |
| Drug class | Quinolone Antimicrobial |
| Target | Gamma-aminobutyric acid receptor subunit alpha-1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Abdominal abscess
- Acute Moraxella catarrhalis bronchitis
- Acute bacterial bronchitis
- Acute bacterial peritonitis
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Acute gonococcal cervicitis
- Acute gonococcal endometritis
- Acute gonococcal urethritis
- Acute maxillary sinusitis
- Acute osteomyelitis
- Anthrax
- Bacterial Corneal Ulcer Infection
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Bacterial urinary infection
- Bacteroides Endomyometritis
- Bacteroides Pelvic Cellulitis
- Bacteroides Postpartum Infection
Common side effects
Drug interactions
- dronedarone
- prednisolone
- prednisone
- sucralfate
- theophylline
- tizanidine
- warfarin
Key clinical trials
- Mortality Control Program for Economically Productive Age Group in Tribal Area of Melghat. (PHASE4)
- A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
- Comparative Study of Secondary Prophylaxis for SBP (PHASE4)
- Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial) (NA)
- An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions (PHASE1)
- Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients (PHASE2)
- Antibiotic Profile of Pathogenic Bacteria Isolated in Public Hospitals in Northern Jordan
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Noroxin CI brief — competitive landscape report
- Noroxin updates RSS · CI watch RSS