TheraRadar
Data updated: May 26, 2026

CEFTIN (cefuroxime axetil)

Trial Activity: Mature 5 active trials
Infectious Disease Approved 1987-12-28
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Odense University Hospital conducting 2 trials (17%)
17 indications explored (Broad Platform)
→ antibiotic prophylaxis (2 trials)
→ infection (2 trials)
→ acute uncomplicated diverticulitis (1 trials)
8
Indications
--
Phase 3 Trials
38
Years on Market

Details

Status
Discontinued
First Approved
1987-12-28
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION

Companies

GSK
Active Ingredient: CEFUROXIME AXETIL

CEFTIN Approval History

1988
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Original
New Indication
New Form
Label Update
190 FDA actions from 1987 to 2021 · 6 indication expansions
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label
Apr 2019 SUPPL
Label · Labeling
FDA Letter Label
Oct 2017 SUPPL
Label · Labeling
FDA Letter Label

What CEFTIN Treats

8 FDA approvals

Originally approved for its first indication in 1987 . Covers 8 distinct patient populations.

  • Other (8)
📋

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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

CEFTIN FDA Label Details

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Data Sources

FDA Approval: NDA050605 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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