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 potassium permanganate label claim - 2007 [abstract]. Annual Drug Approval Coodination Workshop. 13:92. Interpretive Summary:
Technical Abstract: 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. Various aspects of these technical sections will be open for discussion. Potassium Permanganate Initial Label Claim (Columnaris on catfish/HSB): 1) Human Food Safety - Complete for all fin fish (07/26/1999). 2) Effectiveness – Preliminary experiments are being conducted with columnaris and hybrid striped bass/channel catfish prior to preparation of a study protocol. 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.