PAROMOMYCIN SULFATE · Sun Pharma
Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN Capsules and other antibacterial drugs, HUMATIN Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Details
- Status
- Discontinued
- First Approved
- 1969-03-24
- 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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Other CDER-designated drugs from the same sponsor (2016–2025).
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 intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In...
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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.