Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract only
Publication Acceptance Date: 6/30/2010
Publication Date: 8/3/2010
Citation: Straus, D.L. 2010. Status of Copper Sulfate - 2010 [abstract]. Annual Drug Approval Coodination Workshop. 16:109. 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. Initial Label Claim (Ich on catfish): 1) Human Food Safety - Complete for all fin fish - February 2004. This includes human intestinal microflora issues, residue chemistry, and microbial food safety with respect to resistance. Hazard characterization requested by FDA/CVM; submitted April 2008. Complete for all fin fish - October 2008. 2) Effectiveness - Complete for Ich for all fish - December 1998. Needs FOI. 3) Target Animal Safety - Complete for channel catfish - April 2006. 4) Environmental Assessment - Submitted to FDA/CVM in December 2006; revisions requested. To be addressed. 5) Label - Draft was concurred by FDA/CVM in May 2008. Sponsor will submit final label. 6) All Other Information - Supplemental Label Claim (Fungus on catfish eggs): 1) Effectiveness – Supportive Range-Finding and Dose-Confirmation studies to control egg mortality associated with Saprolegniasis were completed (July 2008). Supportive Final Study Report submitted June 2010. Pivotal Final study reports being prepared. 2) Target Animal Safety - Complete for channel catfish eggs - May 2010. 3) Environmental Assessment - To be addressed.