CEFOXITIN (cefoxitin sodium) · Hikma
: Treatment: CEFOXITIN FOR INJECTION, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-07-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CEFOXITIN Approval History
What CEFOXITIN Treats
14 indicationsCEFOXITIN is approved for 14 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lower Respiratory Tract Infections
- Pneumonia
- Lung Abscess
- Urinary Tract Infections
- Intra-Abdominal Infections
- Peritonitis
- Intra-Abdominal Abscess
- Gynecological Infections
- Endometritis
- Pelvic Cellulitis
- Pelvic Inflammatory Disease
- Septicemia
- Bone and Joint Infections
- Skin and Skin Structure Infections
CEFOXITIN 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 CEFOXITIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT06860802 PANDA | HUM00263447 R01HS027788 | Ph 1 | recruiting | Precision Antibiotic Dosing for Appendectomy |
| NCT03269994 results posted | 17-418 | Ph 3 | completed | Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy? |
| NCT02474706 COLIFOX | PHRC N 2013/COLIFOX-MAY/SR | Ph 4 | terminated | Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli |
| NCT02703857 PROPHYLOXITINE | PROPHYLOXITINE | Ph 4 | completed | Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique |
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.
CEFOXITIN FDA Label Details
Indications & Usage
: Treatment: CEFOXITIN FOR INJECTION, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. Urinary tract infections caused by Esc...
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CEFOXITIN IN PLASTIC CONTAINER
Full clinical data, patents, trials, and competitive landscape for cefoxitin sodium.
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