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Data updated: Mar 10, 2026

CEFUROXIME

CEFUROXIME
Infectious Disease Approved 2004-01-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-01-09
Routes
Injection
Dosage Forms
Injectable

Companies

Hikma
Active Ingredient: CEFUROXIME

CEFUROXIME Approval History

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What CEFUROXIME Treats

8 indications

CEFUROXIME is approved for 8 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lower Respiratory Tract Infection
  • Pneumonia
  • Urinary Tract Infection
  • Skin and Skin-Structure Infection
  • Septicemia
  • Meningitis
  • Gonorrhea
  • Bone and Joint Infection
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

CEFUROXIME FDA Label Details

Pro

Indications & Usage

Cefuroxime for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , and Escherichia coli . Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. Skin and Skin­-Structure Infections caused by Staphylo...

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Data Sources

FDA Approval: ANDA065048 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.