COLLABORATIVE EFFORT TO GAIN FDA-APPROVAL FOR USE OF TRIANGLE BRAND (C) COPPER SULFATE AS AN AQUACULTURE THERAPEUTANT
Harry K. Dupree Stuttgart National Aquaculture Research Center
2012 Annual Report
1a.Objectives (from AD-416):
Collaborate in planning/conducting research, preparing submissions and providing other input to gain an FDA-approved label for use of Triangle Brand (c) Copper Sulfate as an aquaculture therapeutant. Label claims will be for:.
1)the treatment of ichthyophthiriasis (Ichthyophthirius multifiliis) on Ictalurid catfish cultured in earthen ponds and.
2)to control egg mortality associated with Saprolegniasis infecting channel catfish eggs.
1b.Approach (from AD-416):
The Food & Drug Administration (FDA) must approve any label claim of a particular drug/compound used to treat a specific disease. Requirements by FDA include the five major technical sections:.
1)Chemistry, Manufacturing, and Controls,.
3)Human Food Safety,.
4)Target Animal Safety, and.
5)Environmental Safety, and two minor technical sections:.
1)All Other Information and.
2)Labeling. Signatories to this agreement will collaborate in joint efforts on all technical sections to gain FDA-approval for use of Triangle Brand (c) Copper Sulfate as an aquaculture therapeutant by developing and exchanging data corresponding to the specialty of each entity.
This project provides input to gain an FDA approved label for use of Triangle Brand Copper Sulfate as an aquaculture therapeutant. Both parties are collaborating to develop and exchange data corresponding to the specialty of each entity. Technical studies have been completed, and reports have been prepared for the cooperator to submit to FDA; the report titles are "A Laboratory Dose Confirmation Experiment on the Use of Copper Sulfate to Control Egg Mortality Associated with Saprolegniasis Infecting Channel Catfish Eggs" and the follow-up report "A Field Study Dose Confirmation Experiment on the Use of Copper Sulfate to Control Egg Mortality Associated with Saprolegniasis Infecting Channel Catfish Eggs".