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Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other Publication Acceptance Date: 11/8/2010 Publication Date: 11/15/2010 Citation: Straus, D.L. 2010. USDA’s Corner. Aquatic Animal Drug Approval Partnership (AADAP). 6(3):11. Interpretive Summary: Technical Abstract: The 17a-methyltestosterone Target Animal Safety study with tilapia was completed early this summer and we are finalizing the QA audit with an ‘in-life study’ report. We are also assisting AADAP with compiling a draft of the Final Study Report for FDA. We will present findings with respect to acute and chronic toxicity, fish growth, and feeding behavior at the upcoming Aquaculture America 2011 meeting in New Orleans. We would like to thank the Western Regional Aquaculture Center (especially Graham Young and Sarah Merlino) for funding this study. We are awaiting an FDA response to our submission of a Final Study Report for the supportive effectiveness range-finding studies of CuSO4 on fungus of channel catfish eggs that was sent in June. We continue our catfish studies with columnaris in the low-flow aquarium system with tests on KMnO4 and CuSO4. We have worked with the effectiveness of KMnO4, CuSO4and peracetic acid on an Ichthyobodo (Costia) infestation in catfish and in sunshine bass. We also researched the effectiveness of formalin and CuSO4 on gill flukes in white bass. Finally, we have an exciting agenda lined up for the “Aquaculture Drug Research and Drug Approval Status” special session at AA 2011. As in the past, the session will provide an opportunity for those conducting studies on drugs/chemicals for use in aquaculture and fisheries to present their findings. In addition, there will be a presentation at the end of the session where we’ll update attendees on the status of three (or more) drugs/chemicals important to fish culturists. This presentation will be scheduled as the last presentation to allow time for questions and answers and discussion of the status of other aquaculture drugs. We will start the session off with presentations from FDA about the approval process for animal drugs, and considerations when evaluating effectiveness trials for antiparasitic drug claims. The rest of the session will focus on technical presentations of current research, and will include presentations on: the safety of 17a-methyltestosterone medicated feed to tilapia, acute toxicity of diquat to freshwater prawn, comparing the efficacy of fungicides on channel catfish eggs, treatments of copper sulfate and formalin on gill flukes and Ich in white bass, use of peracetic acid as a fungicide on catfish eggs, use of florfenicol in recirculating aquaculture systems, effects of overdosing yellow perch with Aquaflor® medicated feed, controlling mortality in Chinook salmon from BKD using Aquaflor® medicated feed, and use of Slice® to reduce infestations of Salmincola in rainbow trout. The drug approval status presentations will provide an overview of activities relating to the approval of channel catfish pituitary (as a spawning aid) and Aqui-S® E, Halamid®, and expanding label claims for Aquaflor®. |
