Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract Only
Publication Acceptance Date: 5/7/2016
Publication Date: 7/15/2016
Citation: Straus, D.L. 2016. Status of copper sulfate research at SNARC. Annual Drug Approval Coodination Workshop. Available: https://www.fws.gov/fisheries/aadap/22nd-AADAP-Coordination_meeting/5-Straus_CuSO4.pdf.
Technical Abstract: An overview of the Technical Sections completed and being worked on for the New Animal Drug Application (NADA) for copper sulfate will be given. The change in Sponsorship will also be discussed. The Initial label claim will be “For the treatment of ichthyophthiriasis (Ichthyophthirius multifiliis) on Ictalurid catfish cultured in earthen ponds.” The Technical Sections are: 1) Human Food Safety - Complete for all fin fish, 2) Effectiveness - Complete for Ich for all fish, 3) Target Animal Safety - Complete for channel catfish, 4) Environmental Assessment – Approved by FDA/CVM (Environmental Impact for earthen ponds complete letter requested by Sponsor), 5) Label - Draft was concurred by FDA/CVM; sponsor will submit final label, and 6) All Other Information; to be addressed. The supplemental label claim will be “To control egg mortality associated with saprolegniasis infecting channel catfish eggs.” The Technical Sections are: 1) Human Food Safety - Complete for all fin fish, 2) Effectiveness –Complete for channel catfish eggs, 3) Target Animal Safety - Complete for channel catfish eggs, and 4) Environmental Assessment; to be addressed. Other copper sulfate research to be discussed: 1) Control of columnaris in catfish, and 2) fungus control on various fish eggs.