The Aquatic Animal Drug Approval Partnership is a fish medicine research and development program.   

This small team of research professionals contribute thousands of hours in the lab and field to make sure that fisheries managers across the country have access to a well-stocked fish medicine chest. The Aquatic Animal Drug Approval Partnership program is part of the Fish and Aquatic Conservation’s fish health work and is the only program in the United States singularly dedicated to obtaining U.S. Food and Drug Administration approval of new medications needed for use in fish culture and fisheries management.  

Safe and effective medications improve the health of aquatic animals.  

When fisheries professionals have more options for medications, they are better equipped to rear healthy fish, manage healthy aquatic populations, and maintain a healthy environment. 

Since the late 1990’s, the Aquatic Animal Drug Approval Partnership has contributed to the majority of new fish medications approved by the FDA. Ultimately, this work 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. Since 1999 the Aquatic Animal Drug Approval Partnership’s National Investigational New Animal Drug Program has: 

• Conducted 13,000 studies to ensure medications are safe to aquatic animals.
• Treated 1.5 billion aquatic animals.
• Saved 50 million fish each year for restoration, recovery, recreation, or the dinner table. 

Aquatic Animal Drug Approval Partnership programs work to:

• Oversee the National Investigational New Animal Drug Program.
• Work with sponsors towards new animal drug approvals.
• Maintain an applied research program. 

The Aquatic Animal Drug Approval Partnership’s Outreach Program provides the U.S. aquaculture community with up-to-date information on the status, availability, and use guidance of aquatic animal medications.  This ensures they are safe, effective, and legal when used in aquaculture and fisheries management. 

AQUI-S E10% Approval

The FDA has approved AQUI-S E10% (eugenol immersion solution) as a sedative for field use to sedate freshwater finfish to a handleable condition. This approval is limited to field use, meaning only wild fish populations can be treated. Because the approved sedation is for a handleable condition only, the use is intended to sedate fish for safe handling during resource management activities such as spawning, tagging, weighing, and measuring. The use of AQUI-S E10% to sedate fish reared in aquaculture or a hatchery setting is not yet approved; legal use in a hatchery setting can be obtained through AADAP's INAD Program.

The dosing regimen under this approval is 25–40 mg/L AQUI-S E10% for freshwater salmonids or 40–100 mg/L AQUI-S E10% for freshwater non-salmonids.

Interested parties can find more information in the FDA's announcement.

What is AQUI-S E10%?
AQUI-S E10% is a liquid containing 10% eugenol and has previously been known as Aqui-S 20E. The product name was changed to more clearly represent the percentage of eugenol used as the active ingredient. The formulation has not changed, only the product name. All references to the product (including approved or INAD uses) will be using the AQUI-S E10% name moving forward.

Why does field use differ from use in a hatchery?

When a sedative is used in the field there are typically less fish treated and sampling is more often conducted in a remote area. These factors reduce the likelihood that a treated fish would be captured and consumed by a human prior to the 72-hour withdrawal period that is required when AQUI-S E10% is used in a hatchery setting.

We are still working on getting AQUI-S E10% approved for use in a hatchery or aquaculture setting. The required withdrawal period for fish treated in a hatchery (72-hrs) differs from the immediate release that is allowed when fish are treated in the field (for the reasons listed above). This difference in required withdrawal periods is why field use and hatchery use are under difference indications and therefore have not been approved simultaneously.  

What does this mean for INAD use?

Any uses of AQUI-S E10% outside of the approved indication are still required to be conducted under AADAP's INAD (11-741). This includes use of AQUI-S E10% in a hatchery or aquaculture setting, sedation of any marine species, or for sedation levels of any finfish other than handleable (i.e., light sedation, sedation for surgery, or transport). Additionally, field use for handleable sedation that is outside of the dose regimen on the approved indication (25 – 40 mg/L for freshwater salmonids or 40 – 100 mg/L for freshwater non-salmonids) is required to be conducted under AADAP's INAD (11-741).

How do I purchase the approved product?

The approved product will be sold by Merck.

AADAP will update the AQUI-S E10% INAD protocol to reflect the approval and will reach out to INAD participants with more information regarding current and scheduled field INAD studies.

For additional information on this approval please check out the following links:

• CVM Update
• Freedom of Information Summary - NADA 141-630 
• Guidance for Industry #150: Concerns Related to the Use of Clove Oil as an Anesthetic for Fish (revised, August 2026) 

If you have questions regarding any of the information provided in this AADAP Update, please contact Paige Maskill. 
 

Resources for Aquaculturists 

Resources for Selecting Aquaculture Medications - The fields of aquaculture and fisheries science require safe and effective medications for treating fish diseases and managing fisheries—as well as information to help guide the professionals who administer these medications.  

Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture - Need an easy-to-use resource to help you know what aquaculture drugs are approved by FDA and what they can be used for? Download the Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture (updated July 2020).

Drug Research Information Bulletins - Drug Research Information Bulletins (DRIBs) are short (1-2 pages) that summarize studies the AADAP Research Team has conducted and briefly describe of the purpose of the study, the methodologies, and results/discussion. 

Our Programs and Research

New Animal Drug Approval Assistance Program

We assist sponsors in navigating the FDA’s New Animal Drug Approval process where needed. This involves helping a new sponsor start the approval process and helping current sponsors find ways to keep moving forward in the approval process.

Aquatic Animal Drug Approval Partnership Applied Research Program

Our applied research program conducts studies that evaluate the safety and efficacy of experimental medications. Results of these analyses are used to support U. S. Food and Drug Administration approval of the drug.

Outreach Program

Our researchers, physiologists, nutritionists, and veterinary scientists provide fisheries professionals with up-to-date information about existing and pending drug approvals, as well as extensive drug use guidance information.

National Investigational New Animal Drug Program 

The Aquatic Animal Drug Approval Partnership program sponsors a variety of medications through the U.S. Food and Drug Administration’s Investigational New Animal Drug pathway. Investigational New Animal Drugs are drugs that are in the approval pipeline but are not yet approved by FDA for use in the United States. They are strictly controlled by the FDA’s Center for Veterinary Medicine and the Service’s Aquatic Animal Drug Approval Partnership.   AADAP has a National Investigational New Animal Drug Program that is available to all fish culturists, fish biologists, and fishery managers within the United States and U.S. territories and allows participating facilities to have legal access to a broad variety of medications that are still in the approval process.

Learn more about Aquatic Animal Drug Approval 

How an Aquatic Animal Drug is Approved in the U.S. - Aquatic animal drug approval is a rigorous and expensive process that is necessary to ensure the effectiveness of the drug and its safety for fish, consumers, and the environment. For

Aquatic Animal Drugs Keep Fish Healthy - Safe and effective medications improve the health of aquatic animals. When fisheries professionals have more options for medications, they are better equipped to rear healthy fish, manage healthy aquatic populations, and maintain a healthy environment. 

Partners in the Aquatic Animal Drug Approval Partnership  - The Aquatic Animal Drug Approval Partnership Program works closely with the Association of Fish and Wildlife Agencies’ Drug Approval Working Group to provide a national perspective for the oversight and coordination of collaborative research, field tests, data collection, data analysis, and data submittals to the U.S. Food and Drug Administration.

Follow Along for Updates

The AADAP Updates feature news on aquaculture drugs currently in the U.S. Food and Drug Administration (FDA) approval process, AADAP programmatic updates, and aquaculture drug use guidance information. To receive the AADAP Update, please subscribe. If you encounter any issues, contact beatriz_silva@fws.gov. Thank you!"