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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 potassium permanganate - 2008 [abstract]. Annual Drug Approval Coordination Workshop. 14:71. Interpretive Summary: Technical Abstract: This is a brief overview of the Technical Sections completed and being worked on for the New Animal Drug Application (NADA) for potassium permanganate will be presented. Initial Label Claim (Columnaris on catfish/HSB): 1) Human Food Safety - Complete for all fin fish (June 1999). A hazard characterization is now required. 2) Effectiveness – Preliminary experiments are being conducted with columnaris and hybrid striped bass/channel catfish. 3) Target Animal Safety – New study is planned; awaiting dose determined in the Effectiveness Technical Section. 4) Environmental Assessment – Environmental Fate studies have been completed (under a multi-state conservation grant) and results are being published. Environmental assessment is planned. |