Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract only
Publication Acceptance Date: 6/1/2012
Publication Date: 7/31/2012
Publication URL: http://www.fws.gov/fisheries/aadap/INAD%20Workshop%20Files/Workshop%202012%20LaCrosse/Presentations/Copper%20Sulfate2.pdf
Citation: Straus, D.L. 2012. Copper Sulfate Research at Stuttgart National Aquaculture Research Center [abstract]. Annual Drug Approval Coodination Workshop. Available: http://www.fws.gov/fisheries/aadap/INAD%20Workshop%20Files/Workshop%202012%20LaCrosse/Presentations/Copper%20Sulfate2.pdf. Interpretive Summary:
Technical Abstract: This is brief overview of the Technical Sections completed and being worked on for the New Animal Drug Application (NADA) for copper sulfate. 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; this includes human intestinal microflora issues, residue chemistry, and microbial food safety with respect to resistance and hazard characterization, 2) Effectiveness - Complete for Ich for all fish, 3) Target Animal Safety - Complete for channel catfish, 4) Environmental Assessment – Submitted previously to FDA/CVM; revisions requested; to be addressed, 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) Effectiveness –supportive range-finding final study report has been accepted; pivotal dose-confirmation final study reports are being prepared, 2) Target Animal Safety - Complete for channel catfish eggs, and 3) Environmental Assessment; to be addressed. Other copper sulfate research: 1) Control of columnaris in catfish, and 2) fungus control on hybrid striped bass eggs.