Effectiveness research leading to approvals for controlling mortality in coolwater and warmwater finfish due to aeromonad infections with Terramycin 200 for fish® (oxytetracycline dihydrate) and Aquaflor® (florfenicol).
1. Identify the etiologic agent (Aeromonas spp.) from isolates collected from disease outbreaks in the NCR and characterize the disease syndrome before conducting any effectiveness studies.
2. Have active, established Investigational New Animal Drug (INAD) exemptions or work with the sponsors of publicly disclosable INADs for Terramycin 200 for Fish® and Aquaflor®.
3. Develop draft pivotal effectiveness study protocols with the concurrence of the two drug sponsors (Phibro Animal Health=PAH for Terramycin 200 for Fish® and Schering-Plough Animal Health=SPAH for Aquaflor®).
4. Submit the draft pivotal effectiveness study protocols through established INADs for Terramycin 200 for Fish® and Aquaflor® for protocol concurrence from the CVM before beginning the effectiveness studies.
5. Conduct pivotal effectiveness studies on Terramycin 200 for Fish® and Aquaflor® according to Good Clinical Practice and the CVM concurred protocols.
6. Analyze the effectiveness data and prepare draft final study reports for Terramycin 200 for Fish® and Aquaflor® no more than four months after the studies are completed.
7. Submit the respective draft study reports to PAH and SPAH for their review.
8. Submit the final study reports through established INADs for Terramycin 200 for Fish® and Aquaflor® to CVM for acceptance no more than two months after PAH and SPAH have completed their reviews of the draft study reports.
9. Ensure that all questions and concerns about the final study reports are answered no more than one month after receiving comments from CVM.
10. If CVM accepts the data as proving effectiveness for the aeromonad infections encountered in the NCR, provide the acceptance letter and effectiveness studies to PAH and SPAH so that they can pursue supplemental NADA approvals for their respective drug products.
|Mark P. Gaikowski (U.S. Geological Survey, Upper Midwest Environmental Sciences Center)
|U.S. Fish and Wildlife Survey, La Crosse Fish Health Center
|Becky A. Lasee
|North American Fish Farmers Cooperative
|Schering-Plough Animal Health Corporation
Project Outline (111K)
Project Number: 8
Duration: 9/1/08 - 8/31/10