COLISTIMETHATE SODIUM · Fresenius Kabi
Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Details
- Status
- Prescription
- First Approved
- 1970-06-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COLISTIMETHATE SODIUM Approval History
What COLISTIMETHATE SODIUM Treats
1 indicationsCOLISTIMETHATE SODIUM is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Infections
COLISTIMETHATE SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06488794 ColiPed | FThabet | Ph 2, Ph 3 | not yet recruiting | Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia |
| NCT06893835 MDRS | Multidrug resistance | Ph 4 | active not recruiting | Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline |
| NCT03397914 | 103 | Ph 4 | completed | Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections |
| NCT01863719 | 10-0082 HHSN272201500007I | Ph 1 | terminated | Aerosolized and Intravenous Colistin in Healthy Adults |
| NCT02966457 DEHAM | HEM-3_1 | Ph 4 | completed | A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM) |
| NCT01449838 | 114490 | Ph 1 | completed | Phase I Study of Colistin Methanesulfonate Sodium |
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.
COLISTIMETHATE SODIUM FDA Label Details
Indications & Usage
Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Colistimethate for Injection,...
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Full clinical data, patents, trials, and competitive landscape for colistimethate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.