Submitted to: Annual Drug Approval Coodination Workshop
Publication Type: Abstract Only
Publication Acceptance Date: 7/18/2006
Publication Date: 8/1/2006
Citation: Straus, D.L. 2006. Status of potassium permanganate initial label claim - 2006 [abstract]. Annual Drug Approval Coodination Workshop. 12:155. 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 NADA: 1) Human Food Safety - Complete for all fin fish (07/26/1999). 2) Effectiveness – Preliminary experiments are being conducted with columnaris and 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.