Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other
Publication Acceptance Date: 5/5/2015
Publication Date: 6/16/2015
Citation: Straus, D.L. 2015. USDA's corner in AADAP newsletter. Aquatic Animal Drug Approval Partnership (AADAP). 11(1):16-17.
Technical Abstract: Aquaculture America 2015 The Aquaculture Drug Research and Drug Approval Status special session, which is moderated by Jim Bowker and Dave Straus, was very successful with 8 presentations, a large audience, and plenty of discussion. Copper Sulfate (CuSO4) Chemistry, Manufacturing and Control Technical Section The Office of New Animal Drug Evaluation at FDA/CVM has asked the Sponsor to update the CMC Technical Section. We have obtained copies of the old submission, and the Sponsor is in the process of compiling this information. Ichthyophthiriasis label: All major Technical Sections for this label are Complete except for Environmental Safety. The Environmental Safety technical section for the indication “… to control mortality associated with ichthyophthiriasis on channel catfish cultured in earthen ponds” was submitted 12/19/2014. We await the FDA/CVM response. The Labeling and All Other Information Technical Sections will be submitted pending the status of the Environmental Safety. Saprolegniasis label: All major Technical Sections for this label are Complete except for Environmental Safety under a hatchery scenario. We are in discussions now about funding this Environmental Safety report and hope to get started later this year. Peracetic Acid Acute toxicity studies are in progress at SNARC on a variety of fish species and diseases. Dave Straus and Thomas Meinelt (Berlin, Germany) met with several companies at the recent Aquaculture America meeting and were notified that they have decided to market a peracetic acid product for use in aquaculture as a disinfectant. This was the goal of Dave and Thom when they started their collaboration 8 years ago. Dave Straus, USDA/ARS, Harry K. Dupree – Stuttgart National Aquaculture Research Center, Stuttgart, AR.