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Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other Publication Acceptance Date: 9/1/2013 Publication Date: 9/1/2013 Citation: Straus, D.L. 2013. USDA's Corner. Aquatic Animal Drug Approval Partnership (AADAP). p.8. Interpretive Summary: Technical Abstract: Aquaculture America 2014 The Aquaculture Drug Research and Drug Approval Status special session which is moderated by Jim Bowker and Dave Straus has decided to take a break after 11 years. We will return for the Aquaculture America 2015 meeting in New Orleans. Keep us in mind as we hope to have a good turn-out in 2015! Copper Sulfate (CuSO4) Chemistry, Manufacturing and Control Technical Section The Biotherapeutics Team of the Division of Manufacturing Technologies in the Office of New Animal Drug Evaluation at FDA/CVM has asked the Sponsor to update the CMC Technical Section. We are in the process of assisting him with this task. Saprolegniasis label: Effectiveness dose-confirmation Final Study Reports (lab and field) for the study on CuSO4 to control fungus on channel catfish eggs were completed at SNARC and submitted to FDA/CVM in November 2012 and March 2013 by the sponsor. They received a Technical Section Complete letter dated June 12, 2013. As you know, this is a significant accomplishment towards gaining approval of copper sulfate to treat fungus on eggs. This completes all major technical sections except for Environmental Safety under a hatchery scenario. Ichthyophthiriasis label: The Environmental Safety technical section for the indication “… to control mortality associated with ichthyophthiriasis on channel catfish cultured in earthen ponds” has been prepared at SNARC and is being completed by the Sponsor’s environmental consultant. A draft label has been prepared and “all other information” is being compiled. Peracetic Acid Acute toxicity and effectiveness studies are in progress at SNARC on a variety of fish species and diseases. |
