TheraRadar
Data updated: May 26, 2026

HUMATIN (paromomycin sulfate)

Infectious Disease Approved 1969-03-24
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
57
Years on Market

Details

Status
Discontinued
First Approved
1969-03-24
Routes
ORAL
Dosage Forms
CAPSULE, SYRUP

Companies

PARKEDALE PARKE DAVIS Pfizer
Active Ingredient: PAROMOMYCIN SULFATE

HUMATIN Approval History

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Original
New Indication
New Form
Label Update
6 FDA actions from 1969 to 2002
Apr 2002 SUPPL
Mfg · Manufacturing (CMC)
Oct 1992 SUPPL
Mfg · Manufacturing (CMC)
Jan 1981 ORIGINAL
Update

What HUMATIN Treats

2 FDA approvals

Originally approved for its first indication in 1969 . Covers 2 distinct patient populations.

  • Other (2)
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

HUMATIN FDA Label Details

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Data Sources

FDA Approval: ANDA060521 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.