CEFTRIAXONE SODIUM · Hikma
Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that...
Development Insights
Details
- Status
- Prescription
- First Approved
- 1984-12-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CEFTRIAXONE SODIUM Approval History
What CEFTRIAXONE SODIUM Treats
11 indicationsCEFTRIAXONE SODIUM is approved for 11 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lower Respiratory Tract Infections
- Acute Bacterial Otitis Media
- Skin and Skin Structure Infections
- Urinary Tract Infections
- Gonorrhea
- Pelvic Inflammatory Disease
- Bacterial Septicemia
- Bone and Joint Infections
- Intra-abdominal Infections
- Meningitis
- Surgical Prophylaxis
CEFTRIAXONE SODIUM 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 CEFTRIAXONE SODIUM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04975945 | generalsurgery/2021/01 | Ph 4 | withdrawn | Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI |
| NCT01254344 results posted | 0826-056 | Ph 3 | completed | Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056) |
| NCT01473836 results posted | A6831005 | Ph 3 | completed | A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection |
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.
CEFTRIAXONE SODIUM FDA Label Details
Indications & Usage
Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibil...
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CEFTRIAXONE
Full clinical data, patents, trials, and competitive landscape for ceftriaxone 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