AADAP Drug Updates

Investigational New Animal Drug (INAD) Updates

Erymicin 200 Injection INAD is Now Available

Authorization has been received from the U.S. Food and Drug Administration Center for Veterinary Medicine for new INAD 12-781 for the use of erythromycin (Erymicin 200 Injection) treatment to control bacterial kidney disease (BKD; causative agent Renibacterium salmoninarum) in salmonids. More specifically, Erymicin 200 Injection treatment may be used to 1) control mortality caused by BKD in salmonid species, and 2) reduce or minimize R. Salmoninarum levels in BKD positive female salmonid broodstock in order to control (prevent) the vertical transmission of R. Salmoninarum to eggs/progeny.

Bacterial kidney has long posed a serious health concern in both cultured and free-ranging salmonid populations, and we are pleased to announce this opportunity for not only a new BKD treatment option, but also for AADAP to begin cooperatively generating safety and effectiveness data that can ultimately be used to support FDA-approval of Erymicin 200 Injection for use in aquatic species.

Please note we are unable to update the online INAD database at this time. For now all signups will be through paper enrollment and all data collected on paper forms. Please submit the Erymicin 200 Injectable forms to Bonnie_Johnson@fws.gov. Visit the Erymicin 200 Injection fact page for additional information

Immediate Release for Marine and Freshwater Finfish for Field Research

We have recently received authorization from the U.S. Food and Drug Administration Center for Veterinary Medicine for the immediate release of marine finfish for field based fishery management activities under AQUI-S® 20E INAD 11-741. This means all freshwater AND marine finfish that are sedated with AQUI-S®20E at 10 — 100 mg/L for up to 15 min, as part of field-based fishery management activities, may be released immediately after treatment. Hatchery use of AQUI-S®20E for both freshwater and marine finfish still requires a 72 hr withdrawal period before stocking or release; however, fish that are illegal for harvest may be released immediately. All AQUI-S®20E work must be done under approved INAD 11-741.

Visit the Aqui-S 20E fact page for additional information.

 

New Aquaculture Approvals

Halamid® Aqua (Chloramine-T) Approved by FDA to Treat Fish Diseases

Axcentive SARL announced that the U.S. Food and Drug Administration (FDA) Center has approved Halamid® Aqua (100% chloramine-T) as a new therapeutic drug for use in fish. Halamid® Aqua is an important weapon in the arsenal fisheries professionals use to combat fish diseases, and its approval is a major advance in fish health management. Halamid® Aqua is only the 2nd waterborne drug approved to treat fish diseases in nearly 30 years. This approval is a HUGE milestone for those involved in fish culture and fish health, as well as for the public and private-sector partners responsible for getting Halamid® Aqua across the finish line. Our thanks to Axcentive SARL, Association of Fish and Wildlife Agencies, USFWS Aquatic Animal Drug Approval Partnership Program, USGS Upper Midwest Environmental Sciences Center, and the National NADA Coordinator!

HALAMID® Aqua can be used to control mortality in:

 

 

All other uses can be done via veterinary prescription or under the USFWS INAD. For more information and to view the full-length press release, visit the AFS Fish Culture Section at https://sites.google.com/site/fishculturesection/this-just-in.

 

AQUAFLOR® Label Expansion

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, recently announced that the U.S. Food and Drug Administration has approved two additional indications for AQUAFLOR® (florfenicol) Type A Medicated Article. The supplemental approval provides (1) for an increase in the maximum daily dosage for freshwater-reared finfish other than freshwater-reared warmwater finfish to provide a dosage range of 10 – 15 mg florfenicol/kg body weight/day and (2) changes the conditions of use to permit the use of florfenicol in recirculating aquaculture systems. AQUAFLOR® can now be used at a dosage of 10 – 15 mg florfenicol/kg fish body weight/d administered in feed for 10 days to control mortality in:

 

 

AQUAFLOR® can also be used at a dosage of 15 mg florfenicol/kg fish body weight/d administered in feed for 10 days to control mortality in:

 

 

More detailed information can be found at the AQUAFLOR® website – www.AQUAFLOR-usa.com – including the latest product bulletin and the new VFD forms.

 

Research Program update

There’s been a little lull in the storm because we’ve completed virtually all of our major projects and are looking out on the horizon for new opportunities. Here’s a snapshot of what we’ve been up to:

AQUI-S®20E (10% EUGENOL)

Sedation to handleable—Currently, all effectiveness and target animal safety data to support a claim of sedation to handleable in freshwater finfish have been submitted to CVM. To date, all reports and requests that have been reviewed by FDA have been accepted.There are two outstanding reports (target animal safety studies done on yellow perch and channel catfish) that have not yet been reviewed by FDA. As such, our commitment to the sponsor and to the Association of Fish and Wildlife Agencies (AFWA) Drug Approval Working Group (DAWG) has been completed. Now, it’s time for us to look into opportunities to generate data to support expanding the initial draft label claim for AQUI-S®20E.

There are two outstanding reports (target animal safety studies done on yellow perch and channel catfish) that have not yet been reviewed by FDA. As such, our commitment to the sponsor and to the Association of Fish and Wildlife Agencies (AFWA) Drug Approval Working Group (DAWG) has been completed. Now, it’s time for us to look into opportunities to generate data to support expanding the initial draft label claim for AQUI-S®20E.

Effectiveness—Recently, we had an opportunity to sedate a variety of coldwater marine fish (Atlantic salmon, steelhead trout, and sablefish) with AQUIS ®20E. Working with collaborators Armin Ramirez (Fish Health Manager, American Gold Seafoods) at their netpen operation in Manchester, Washington, and Tom Flagg, Carlin McCauley, and Chris Tarata at the National Oceanic and Atmospheric Administration (NOAA) Manchester Laboratory, we sedated fish with AQUI-S®20E at the same dose (25 mg/L eugenol) that we have used to sedate freshwater salmonids. This was done to address a CVM concern about whether times to sedation would be comparable between freshwater fish and marine fish. Although we sedated the marine fish at a lower water temperature (9-10°C) than that used to sedate freshwater fish (13-14°C), results were very comparable.

Dr. Jesse Trushenski (Center for Fisheries, Aquaculture, and Aquatic Sciences, Southern Illinois University at Carbondale) provided AADAP with AQUI-S®20E sedation data that support what we observed with coldwater marine fish. One of Dr. Trushenski’s students sedated hybrid striped bass (HSB) at 60 mg/L eugenol in water with a salinity ranging from 0 to 25 ppt (at 5 ppt increments) and at a water temperature of ~23°C. Times to sedation for 30 individually sedated fish ranged from 0.87 to 1.05 min. These results are comparable to
results (0.95 min) obtained when HSB were sedated at 60 mg/L eugenol in trials conducted to support a claim for effectiveness for freshwater finfish. We (AADAP) anticipate that we’ll encounter similar findings when we have an opportunity to sedate a broader range of marine fishes.

On January 27, 2014, AADAP submitted a pivotal efficacy study protocol entitled “The Efficacy of AQUI-S®20E (10% Eugenol) to Sedate a Variety of Finfish to Handleable in Seawater” to CVM for review. We hope to receive CVM concurrence but anticipate an End-Review-Amendment request to address some of their questions and concerns. As usual, stay tuned. Over the past few months, we’ve been evaluating the effectiveness of AQUI-S®20E administered at low concentrations (3-5 mg/L eugenol) to lightly sedate a variety of salmonids and investigating whether the UV-Vis spectrophotometric method to measure eugenol concentrations is accurate and precise at these levels. We’ve generated some great data and are developing a protocol to submit to CVM so that we can get rolling and generate data to help expand the proposed initial draft label claim for AQUI-S®20E.

 

AQUAFLOR® (50% FLORFENICOL)

On January 21, 2014, we submitted a pivotal efficacy study protocol entitled “The Efficacy of AQUAFLOR® (50% Florfenicol; Type A Medicated Article) Administered in Feed to Control Mortality in Seawater-Reared Finfish” to CVM for their review. In anticipation of conducting effectiveness and safety trials to support expanding the current AQUAFLOR® label to include claims for seawater use, we have been running the trap lines looking for partners. We’ve lined up a few and are anxious to get the protocol approved so that we can move forward with helping the sponsor gain approvals for the use of this antibiotic in seawater finfish.