Fish and Aquatic Conservation

Information iconCutthroat trout, just one of many species AADAP works with to secure new approvals for medications used in aquaculture. (Photo: NPS)



Aquatic Animal Drug Approval Partnership

America’s fisheries are among the world’s richest in abundance and diversity. They provide scientific, aesthetic, recreational, commercial, subsistence, cultural, social, and economic benefits. FAC leads aquatic resource management for the Service and strives to invest its resources in the nation’s highest priority aquatic conservation and water-based recreational needs. Fish health is a critical component of healthy fisheries and core to the work of the Fish and Aquatic Conservation Program.

The Aquatic Animal Drug Approval Partnership (AADAP) program is part of the Fish and Aquatic Conservation fish health work. It is the only program in the United States singularly dedicated to obtaining U.S. Food and Drug Administration (FDA) approval of new medications needed for use in fish culture and fisheries management. Since the late 1990’s, AADAP has contributed to virtually every new fish medication approved by the FDA. Ultimately, the AADAP program allows fisheries professionals to more effectively and efficiently rear and manage a variety of fish species to meet production goals, stock healthy fish, and maintain a healthy environment.

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Aquaculture Medications

Information to inform decisions regarding which medication to use, and how to use it. Safe, effective medications for treating fish diseases and managing fisheries—as well as informing the professionals who administer these medications—are growing needs.

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Investigational New Animal Drug

Investigational New Animal Drugs (INADs) are available through the National INAD Program (NIP) and can be used as long as study parameters are met and work is being done to reach full drug approval.

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Research

Researchers use sound science to evaluate the safety and effectiveness of experimental fish medications. Results support FDA approval of the medications.

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Resources

Along with a knowledgeable staff ready to be of assistance, the AADAP program produces and makes available a variety of informational and educational materials, from reference guides to peer-reviewed publications.

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Highlights

AADAP’s Needs for Efficacy Studies

AADAP is on the lookout for facilities with the following conditions/species combinations in which to conduct efficacy studies:

If you know of any facilities with these conditions, please have them contact AADAP directly.  Thank you!


The Unmet Fish Drug Needs Survey: A Summary Report

AADAP, the Association of Fish and Wildlife’s Drug Approval Working Group (AFWA/DAWG), and the National Aquaculture Association (NAA) conducted a nation-wide survey to assess the current and future unmet fish drug needs of hatchery personnel, fish health professionals, and fisheries management biologists across the U.S. The survey was meant to determine fish drug needs related to: 1) freshwater diseases/pathogens of concern to fisheries professionals, 2) non-therapeutic freshwater purposes (spawning, marking, sedation, etc.), and 3) culture and/or management of marine fish species in seawater environments. The survey was sent to federal, state, and private members of the aquaculture community over the time frame of summer 2017 - fall 2018.

View Summary Report


New Label Extension for Parasite-S

In April 2019, Syndel announced an indication addition for Parasite-S!

Previously, Parasite-S was approved for the control of mortality in: (1) all finfish due to external protozoa (Chilodonella, Costia, Epistylis, Scyphidia, Ichthyopthirius, and Trichodina) and monogenetic trematodes (Cleidodiscus, Dactylogyrus, Gyrodactylus); (2) Penaeid shrimp due to protozoan parasites (Bodo, Epistylis and Zoothamnium), and (3) all finfish eggs due to fungi (Saprolegniaceae).

Parasite-S is now also approved for: controlling mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae when administered at a dose of 150 ppm for 60 minutes per day on alternate days for three treatments in tanks and raceways.


New Label Extensions for 35% PEROX-AID

On July 31st, the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) announced label extensions for 35% PEROX-AID for use in freshwater finfish!

Previously, 35% PEROX-AID was approved for the control of mortality in: (1) freshwater-reared finfish eggs due to Saprolegniasis; (2) freshwater-reared salmonids due to Bacterial Gill Disease (Flavobacterium branchiophilum); and (3) freshwater-reared coolwater finfish and channel catfish due to external columnaris disease (Flavobacterium columnare). 

35% PEROX-AID is now also approved for: (1) controlling mortality in all coldwater finfish (including all salmonids), and all fingerling and adult freshwater-reared coolwater and warmwater finfish due to Saprolegniasis.  This will allow for the treatment of Saprolegniasis in life stages other than eggs; (2) controlling Gyrodactylus spp. in freshwater-reared salmonids; and (3) controlling mortality in all freshwater-reared warmwater finfish, including hybrid catfish and blue catfish, due to external columnaris (Flavobacterium columnare).
According to the FDA press release, "This approval will help provide a critical treatment for improving fish health. The agency also anticipates that resource management agencies will use this approved treatment for aiding in the restoration of certain freshwater fish populations."


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