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Cefditoren Pivoxyl (CEFDITOREN PIVOXIL)
Cefditoren Pivoxyl (generic name: CEFDITOREN PIVOXIL) is a Cephalosporin Antibacterial Small molecule drug developed by Vansen Pharma. It is currently FDA-approved (first approved 2001) for Acute exacerbation of chronic bronchitis, Bacterial pneumonia, Haemophilus Influenzae Chronic Bronchitis.
Cefditoren Pivoxil is a cephalosporin antibacterial drug, originally developed and currently owned by Vansen Pharma. It was FDA-approved in 2001 for various respiratory infections, including acute exacerbation of chronic bronchitis and bacterial pneumonia. As an off-patent drug, it is no longer protected by active patents, but there are currently no generic manufacturers. Cefditoren Pivoxil is a small molecule that targets a range of bacterial pathogens, including Haemophilus influenzae and Staphylococcus aureus. It is used to treat infections caused by these bacteria.
At a glance
| Generic name | CEFDITOREN PIVOXIL |
|---|---|
| Sponsor | Vansen Pharma |
| Drug class | Cephalosporin Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
- Acute exacerbation of chronic bronchitis
- Bacterial pneumonia
- Haemophilus Influenzae Chronic Bronchitis
- Haemophilus Parainfluenzae Chronic Bronchitis
- Haemophilus Parainfluenzae Pneumonia
- Haemophilus influenzae pneumonia
- Infection due to Staphylococcus aureus
- Moraxella Catarrhalis Chronic Bronchitis
- Moraxella Catarrhalis Pneumonia
- Pneumococcal pneumonia
- Streptococcal tonsillitis
- Streptococcus Pneumoniae Chronic Bronchitis
- Streptococcus pyogenes infection
Common side effects
- Hematuria
- Diarrhea
- Increased urine white blood cells
- Decreased hematocrit
- Increased glucose
- Nausea
- Abnormal dreams
- Allergic reaction
- Anorexia
- Asthenia
- Asthma
- Coagulation time increased
Serious adverse events
- Pseudomembranous colitis
- Anaphylaxis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Serum sickness-like reaction
- Erythema multiforme
- Aplastic anemia
- Hemolytic anemia
- Toxic nephropathy
- Seizures
Key clinical trials
- Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics (NA)
- Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women (NA)
- Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia (PHASE4)
- Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis (PHASE4)
- Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis (PHASE3)
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:
- Cefditoren Pivoxyl CI brief — competitive landscape report
- Cefditoren Pivoxyl updates RSS · CI watch RSS
- Vansen Pharma portfolio CI
Frequently asked questions about Cefditoren Pivoxyl
What is Cefditoren Pivoxyl?
What is Cefditoren Pivoxyl used for?
Who makes Cefditoren Pivoxyl?
What is the generic name of Cefditoren Pivoxyl?
What drug class is Cefditoren Pivoxyl in?
When was Cefditoren Pivoxyl approved?
What development phase is Cefditoren Pivoxyl in?
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Related
- Drug class: All Cephalosporin Antibacterial drugs
- Manufacturer: Vansen Pharma — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute exacerbation of chronic bronchitis
- Indication: Drugs for Bacterial pneumonia
- Indication: Drugs for Haemophilus Influenzae Chronic Bronchitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing