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Factive (GEMIFLOXACIN)
Factive (Gemifloxacin) is a quinolone antimicrobial small molecule developed by LG Life Sciences and currently owned by LG Chem Ltd. It was FDA-approved in 2003 for various respiratory infections, including acute bacterial bronchitis, pneumonia, and exacerbation of chronic bronchitis. Factive is off-patent and has a generic manufacturer. Its half-life is approximately 8.3 hours. Key safety considerations include potential side effects such as nausea, diarrhea, and liver enzyme elevations.
At a glance
| Generic name | GEMIFLOXACIN |
|---|---|
| Sponsor | Lg Chem Ltd |
| Drug class | Quinolone Antimicrobial |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
- Acute bacterial bronchitis
- Acute exacerbation of chronic bronchitis
- Bacterial pneumonia
- Chlamydial pneumonia
- Haemophilus influenzae pneumonia
- Moraxella Catarrhalis Pneumonia
- Pneumococcal pneumonia
- Pneumonia due to Klebsiella pneumoniae
- Pneumonia due to Mycoplasma pneumoniae
Common side effects
- Headache
- Nausea
- Rash
- Diarrhea
- Abdominal pain
- Dizziness
- Vomiting
- Increased ALT
- Increased platelets
- Increased AST
- Urticaria
- Increased creatine phosphokinase
Serious adverse events
- Rash
- Nausea
- Diarrhea
- Urticaria
- Vomiting
- Photosensitivity/phototoxicity reactions
- Thrombocytopenia
- Granulocytopenia
- Eosinophilia
- Anemia
Drug interactions
- High Risk QT Prolonging Agents
- dronedarone
- hydrocortisone
- methylprednisolone
- prednisolone
- prednisone
Key clinical trials
- A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
- EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE AND ECG MORPHOLOGY OF EUGLYCEMICS:A CLINICAL STUDY (PHASE1)
- Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis (PHASE3)
- Fluoroquinolone Associated Disability
- Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma (EARLY_PHASE1)
- Efficacy of Combination Therapies for Gonorrhea Treatment (PHASE4)
- Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection (PHASE3)
- An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment
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:
- Factive CI brief — competitive landscape report
- Factive updates RSS · CI watch RSS
- Lg Chem Ltd portfolio CI