CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL is indicated for the treatment of Acute Otitis Media; Pharyngitis; Tonsillitis; Community-Acquired Pneumonia; Acute Bacterial Exacerbation of Chronic Bronchitis.
Details
- Status
- Prescription
- First Approved
- 2002-05-31
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
CEFPODOXIME PROXETIL Approval History
What CEFPODOXIME PROXETIL Treats
5 indicationsCEFPODOXIME PROXETIL is approved for 5 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Otitis Media
- Pharyngitis
- Tonsillitis
- Community-Acquired Pneumonia
- Acute Bacterial Exacerbation of Chronic Bronchitis
CEFPODOXIME PROXETIL 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 CEFPODOXIME PROXETIL
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 |
|---|---|---|---|---|
| NCT03491748 | CS0282-2017-0001 1010452 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants |
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.
CEFPODOXIME PROXETIL FDA Label Details
Indications & Usage
FDA Label (PDF)CEFPODOXIME PROXETIL is indicated for the treatment of Acute Otitis Media; Pharyngitis; Tonsillitis; Community-Acquired Pneumonia; Acute Bacterial Exacerbation of Chronic Bronchitis.
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BANAN
Full clinical data, patents, trials, and competitive landscape for cefpodoxime proxetil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.