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Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract Only Publication Acceptance Date: 7/14/2008 Publication Date: 7/28/2008 Citation: Straus, D.L. 2008. Status of copper sulfate - 2008 [abstract]. Annual Drug Approval Coordination Workshop. 14:70. 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. 2) Effectiveness - Complete for Ich for all fish – December 1998. Needs FOI. 3) Target Animal Safety - Complete for channel catfish - letter dated 4/21/06. Environmental Assessment - Submitted to FDA/CVM in December 2006; revisions requested June 2007; ……... 4) Label – Second draft was submitted to FDA/CVM in May 2008. Sponsor will submit final label when concurrence (??) is reached. 5) All Other Information - Supplemental Label Claim (Fungus on catfish eggs): 1) Effectiveness – Range-finding and Dose-Confirmation studies to control egg mortality associated with Saprolegniasis have been recently completed (July 2008). Final study reports will be compiled. 2) Target Animal Safety – Study has been recently completed (July 2008). Final study report will be compiled. 3) Environmental Assessment - |
