Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract Only
Publication Acceptance Date: 7/20/2007
Publication Date: 7/31/2007
Citation: Straus, D.L. 2007. Status of opper sulfate - 2007 [abstract]. Annual Drug Approval Coodination Workshop. 13:90. 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. The update will include information and dates for both the initial label claim (for control of mortality caused by Ich to channel catfish in ponds) and the supplemental label claim (for control of fungus on catfish eggs). Copper Sulfate Initial Label Claim (Ich on catfish): 1) Human Food Safety - Complete for all fin fish - letter dated 02/09/2004 (submitted 05/16/1996). This includes human intestinal microflora issues, residue chemistry, and microbial food safety with respect to resistance. 2) Effectiveness - Complete for Ich for all fish - letter dated 12/15/1998. 3) 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). 4) Environmental Assessment - was submitted to FDA/CVM in December 2006 and we received a comment letter in late June requesting revisions. These comments will be addressed in the coming months and the Environmental Assessment will be re-submitted. Copper Sulfate Supplemental Label Claim (Fungus on catfish eggs): 1) 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. 2) Target Animal Safety - protocols were submitted and reviewed by FDA/CVM and revised accordingly to reach concurrence (5/16/07). Plans are in place to complete the Target Animal Safety technical section studies during next year’s catfish spawning season.