PAROMOMYCIN SULFATE
PAROMOMYCIN SULFATE is indicated for the treatment of Amebiasis; Hepatic Coma.
Details
- Status
- Discontinued
- First Approved
- 1997-06-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
PAROMOMYCIN SULFATE Approval History
What PAROMOMYCIN SULFATE Treats
2 indicationsPAROMOMYCIN SULFATE is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Amebiasis
- Hepatic Coma
PAROMOMYCIN SULFATE 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
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03096457 | ABF-BO-2016-102 | Ph 2, Ph 3 | completed | Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia |
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.
PAROMOMYCIN SULFATE FDA Label Details
Indications & Usage
PAROMOMYCIN SULFATE is indicated for the treatment of Amebiasis; Hepatic Coma.
Looking for the branded version?
HUMATIN
Full clinical data, patents, trials, and competitive landscape for paromomycin sulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.