Submitted to: Meeting Abstract
Publication Type: Abstract only
Publication Acceptance Date: 7/26/2005
Publication Date: 8/1/2005
Citation: Straus, D.L. 2005. Status of potassium permanganate initial label claim [abstract]. Drug Approval Coordination Workshop Meeting Abstract. 11:114. 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. Human Food Safety is complete for all fin fish (07/26/1999). This compound is not used to treat for Ich (as proposed) and preliminary studies indicate it has a low margin of safety; a phone survey indicated that there is a need to look at efficacy with external columnaris. The Target Animal Safety experimental phase was completed 08/25/1999; the Final Study Report has not been worked on and may need to be re-run pending the outcome of the efficacy Technical Section. As far as the Environmental Assessment, Environmental Fate studies are being completed under a multistate conservation grant as initial phase of this Technical Section.