CEFUROXIME AXETIL · CHARTWELL RX
Cefuroxime axetil is a second-generation cephalosporin antibiotic indicated for the treatment of various mild-to-moderate infections caused by susceptible bacteria. Key indications include pharyngitis/tonsillitis, acute bacterial otitis media, and acute bacterial maxillary sinusitis. It is also indicated for acute bacterial exacerbations of chronic bronchitis, uncomplicated skin and skin-structure infections, uncomplicated urinary tract infections, and uncomplicated gonorrhea. Additionally, it is used to treat early Lyme disease (erythema migrans) in adults and pediatric patients 13 years and older. To reduce the development of drug-resistant bacteria, this medication should only be used for infections proven or strongly suspected to be caused by susceptible organisms.
How CEFUROXIME AXETIL Works
Cefuroxime axetil is a bactericidal agent that inhibits bacterial cell wall synthesis. After oral administration, it is absorbed and hydrolyzed to cefuroxime. Cefuroxime acts by binding to essential penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. This binding inhibits the transpeptidation step of peptidoglycan synthesis, which is required for cross-linking the bacterial cell wall. The resulting cell wall instability leads to bacterial cell lysis and death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1987-12-28
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
Companies
CEFUROXIME AXETIL Approval History
What CEFUROXIME AXETIL Treats
9 indicationsCEFUROXIME AXETIL is approved for 9 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pharyngitis
- Tonsillitis
- Acute Otitis Media
- Maxillary Sinusitis
- Skin Infection
- Urinary Tract Infection
- Gonorrhea
- Lyme Disease
- Rheumatic Fever
CEFUROXIME AXETIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CEFUROXIME AXETIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06527560 CEFURO | 2024-0118 | Ph 4 | recruiting | Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CEFUROXIME AXETIL FDA Label Details
Indications & Usage
Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) Acute bacterial otitis media (pediatric patients) Acute bacterial maxillary sinusitis (adults and pediatric patients) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) Uncomplicated urinary tract infections (adults and pediatric patients 13 ye...
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CEFTIN
Full clinical data, patents, trials, and competitive landscape for cefuroxime axetil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment