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Data updated: Jun 28, 2026

MYCIFRADIN (neomycin sulfate) · PHARMACIA AND UPJOHN

Infectious Disease Approved 1971-02-23

MYCIFRADIN is FDA-approved to treat 2 conditions (same as NEOMYCIN SULFATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
55
Years on Market

Details

Status
Discontinued
First Approved
1971-02-23
Routes
ORAL
Dosage Forms
TABLET, SOLUTION

Companies

PHARMACIA AND UPJOHN
Active Ingredient: NEOMYCIN SULFATE

MYCIFRADIN Approval History

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Original
New Indication
New Form
Label Update
34 FDA actions from 1971 to 2009
Mar 2009 ORIGINAL
Update
Oct 1994 SUPPL
Label · Labeling
Feb 1994 SUPPL
Mfg · Manufacturing (CMC)

What MYCIFRADIN Treats

2 indications

MYCIFRADIN is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Intestinal Bacteria Suppression
  • Hepatic Encephalopathy

Same approved indications as NEOMYCIN SULFATE (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT07180615 NeoRiDe 2025-01074 Ph 4 not yet recruiting Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
NCT03557008 results posted IRB00101567 Ph 4 completed Responses to Rabies Vaccine in Adults With or Without Antibiotics
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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.

MYCIFRADIN FDA Label Details

Indications & Usage

MYCIFRADIN is FDA-approved to treat 2 conditions — same approved indications as NEOMYCIN SULFATE.

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Data Sources

FDA Approval: ANDA060520 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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