VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (vancomycin hydrochloride) · Baxter
Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Septicemia • Infective Endocarditis • Skin and Skin Structure Infections • Bone Infections • Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection sh...
Development Insights
Details
- Status
- Prescription
- First Approved
- 1993-04-29
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER Approval History
What VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER Treats
5 indicationsVANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER is approved for 5 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Staphylococcal Endocarditis
- Septicemia
- Bone Infection
- Lower Respiratory Tract Infection
- Skin Infection
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER 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.
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05766670 | W81XWH-22-10937 W81XWH-22-10937 | Ph 3 | recruiting | Intramedullary Calcium Sulfate Antibiotic Depot |
| NCT04500275 | A-BR-109-013 | Ph 4 | completed | Topical Vancomycin Over Sternal Edge in Cardiac Surgery |
| NCT06126614 PREVENT-iT | PiT-2023 | Ph 3 | recruiting | Infection Prophylaxis in Total Joint Replacement |
| NCT07913347 ROOT | MGT-006-UC-G1201 jRCT2071260030 | Ph 1, Ph 2 | recruiting | Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study) |
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.
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Septicemia • Infective Endocarditis • Skin and Skin Structure Infections • Bone Infections • Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused ...
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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