# Efficacy of Romet 30 to control mortality against enteric redmouth disease caused by Yersinia ruckeri in freshwater-reared rainbow trout (Oncorhynchus mykiss).

> **NIH FDA R01** · AQUA TACTICS FISH HEALTH · 2020 · $57,683

## Abstract

SULFADIMETHOXINE AND ORMETOPRIM – FIELD EFFECTIVENESS STUDY IN RAINBOW
TROUT.RESEARCH STRATEGY
Summary
PHARMAQ AS holds NADA 125933 for Sulfadimethoxine and Ormetoprim (Romet®
30), a Type A Medicated Article for use in feed. Current label indications are for the
control of mortality in salmonids against furunculosis disease caused by Aeromonas
salmonicida and in channel catifhs against enteric septicemia caused by Edwardsiella
ictaluri. PHARMAQ AS desires to expand the label indications for NADA 125933. US
FDA Center for Veterinary Medicine drug registration requirements include clinical field
studies to address effectiveness of a proposed label indication.
The study will follow the proposed study protocol submitted on December 4, 2019,
entitled “The Efficacy of Romet® 30 (sulfadimethoxine and ormetoprim Type A
medicated article) Administered in Feed to control mortality caused by susceptible
bacterial pathogens of freshwater-reared finfish. Specifically, this study will assess the
effectiveness of the drug against enteric redmouth disease caused by Yersinia ruckeri in
rainbow trout (Oncorhynchus mykiss). The study will be conducted under subaward by
US Fish and Wildlife Services, Aquatic Animal Drug Approval Partnership, Bozeman,
Montana at an appropriately vetted site undergoing a natural epizootic.

## Key facts

- **NIH application ID:** 10086704
- **Project number:** 1R01FD006918-01
- **Recipient organization:** AQUA TACTICS FISH HEALTH
- **Principal Investigator:** Thomas D Goodrich
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $57,683
- **Award type:** 1
- **Project period:** 2020-06-01 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10086704

## Citation

> US National Institutes of Health, RePORTER application 10086704, Efficacy of Romet 30 to control mortality against enteric redmouth disease caused by Yersinia ruckeri in freshwater-reared rainbow trout (Oncorhynchus mykiss). (1R01FD006918-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10086704. Licensed CC0.

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