Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract Only
Publication Acceptance Date: 7/18/2006
Publication Date: 8/1/2006
Citation: Straus, D.L. 2006. Status of copper sulfate initial label claim - 2006 [abstract]. Annual Drug Approval Coodination Workshop. 12:153. Interpretive Summary:
Technical Abstract: A brief overview of the Technical Sections completed and being worked on for the New Animal Drug Application (NADA) for copper sulfate will be presented. Various aspects of these technical sections will be open for discussion. Copper Sulfate NADA: 1) Human Food Safety - Complete for all fin fish - letter dated 02/09/2004 (submitted 05/16/1996). 2) Effectiveness - Complete for Ich for all fish - letter dated 12/15/1998. 3) Effectiveness – Range-finding studies to control egg mortality associated with Saprolegniasis have been completed and we have finished part of the dose-confirmation study. More dose-confirmation experiments will be repeated during next spawning season to supply FDA/CVM with independent substantiation under different study conditions. 4) Target Animal Safety - Complete for channel catfish - letter dated 4/21/06. (Final Study Report submitted 07/01/2004, study data accepted 5/24/05). 5) Environmental Assessment - Currently being prepared for submission. In a letter dated 5/25/06, ONADE and OMUMS designated copper sulfate's intended use: For the treatment of ichthyophthiriasis (Ichthyophthirius multifiliis) on channel catfish cultured in earthen ponds.