Aquaculture Drugs—Update*Aquaculture Drugs—Update*

Rosalie (Roz) Schnick

Michigan State University

RozSchnick@Centurytel.nethttp://ag.ansc.purdue.edu/aquanic/jsa/aquadrugs/index.htm

*Presented at the National Association of State Aquaculture Coordinators, Louisville, Kentucky, June 2-5, 2004

Major Initiative Nearing Final Major Initiative Nearing Final CompletionCompletion

Federal-State Aquaculture Drug Approval Partnership Project (=IAFWA Project)– Main partners

Aquatic Animal Drug Approval Partnership Program (AADAP)

Upper Midwest Environmental Sciences Center (UMESC) Harry K. Dupree Stuttgart National Aquaculture Research

Center (SNARC)

– Eight years, formal portion ended September 2002– $12+ million– 9 drugs (marked in turquoise)

IAFWA Project Submissions & IAFWA Project Submissions & Acceptances (9/03 – 3/04)Acceptances (9/03 – 3/04)

Drug/Initial Label Claims Submissions AcceptancesAQUI-S®/1 5 4

Copper sulfate/1 0 0

Chloramine-T/2 0 2

Florfenicol/4 4 1

Formalin/3 (2 approved) 1 0

Hydrogen peroxide/4 1 5

Oxytetracycline (oral)/2 0 2

Oxytetracycline (immersion)/4 (1 approved)

1 1

Potassium permanganate/1 0 0

TOTALS=9 Drugs/22 label claims 12 15

IAFWA Project Submissions & IAFWA Project Submissions & Acceptances (9/03 – 3/04)Acceptances (9/03 – 3/04)

Submitter Submissions AcceptancesAADAP 2 (EFF

studies)5 (4 EFF studies, 1 FOI)

Sponsors 7 (2 PC, 4 ES, 1 HFS)

3 (1 PC, 1 TAS, 1 NADA approved)

UMESC 3 (2 EFF, 1 EFF dose)

7 (3 TAS, 4 EFF Technical sections)

TOTAL 12 15

STATUS OF EFFORTS STATUS OF EFFORTS TOWARD APPROVALS—TOWARD APPROVALS—

AQUACULTURE AQUACULTURE THERAPEUTANTSTHERAPEUTANTS

Completed or Nearing Completion—Completed or Nearing Completion—Oral AntibacterialsOral Antibacterials

Erythromycin (BPA, NRSP-7, University of Idaho)– Bacterial kidney disease—salmon

Florfenicol (was IAFWA Project, MCGP, & sponsor)– Furunculosis columnaris disease—freshwater-reared

salmonids (AADAP, UMESC)– Coldwater disease—freshwater-reared salmonids

(AADAP, UMESC)– Enteric septicemia—catfish (UMESC)– Systemic columnaris disease—freshwater-reared

salmonids & catfish (AADAP & UMESC)

Completed or Nearing Completion—Completed or Nearing Completion—Oral Antibacterials (continued)Oral Antibacterials (continued)

Oxytetracycline (oral)—approvals—various diseases—catfish, salmonids, & lobsters– Coldwater disease—all freshwater-reared salmonids (AADAP,

UMESC) – Systemic columnaris disease—steelhead trout (AADAP,

UMESC) Romet-30®—approvals—various diseases—catfish &

salmonids– Romet-TC®—improved palatability for top coating—accepted

November 2003 Sulfamerazine—approved for furunculosis—salmonids

(sponsor not currently distributing product)

Work Underway—Work Underway—Oral Antibacterials (continued)Oral Antibacterials (continued)

Amoxicillin (sponsor, Kent SeaTech, NRSP-7, SNARC)– Streptococcus—hybrid striped bass & tilapia (work

underway)

Oxytetracycline (oral)—approvals for catfish, salmonids, and lobsters– Systemic bacterial diseases—flounder and tilapia

(NRSP-7)– Streptococcus—tilapia (SNARC)

Nearing Completion—Nearing Completion—External antibacterialsExternal antibacterials

Chloramine-T (IAFWA Project and sponsor)– Bacterial gill disease—all freshwater-reared salmonids

(AADAP, UMESC)– External columnaris disease—walleye (UMESC)

Nearing Completion—External Nearing Completion—External antibacterials (continued)antibacterials (continued)

Hydrogen peroxide (IAFWA Project)– Bacterial gill disease—all freshwater-reared salmonids (UMESC)– External columnaris disease—all coolwater fish & channel catfish

(UMESC)

Oxytetracycline immersion (IAFWA Project & MCGP)– Bacterial gill disease—coolwater & warmwater fish (UMESC)– External columnaris disease—coolwater & warmwater fish

(UMESC)– Systemic columnaris disease—coolwater & warmwater fish

(UMESC)

Work Underway or Possibility—Work Underway or Possibility—External antibacterials (continued)External antibacterials (continued)

Copper sulfate (IAFWA Project)– Possibility for development (SNARC)

Potassium permanganate (IAFWA Project)– Possibility for development (SNARC)

Pyceze® (sponsor)– Early development stage

Completed or Nearing CompletionCompleted or Nearing Completion—Fungicides (control —Fungicides (control

saprolegniasis)saprolegniasis)

Formalin—salmon, trout, & esocid eggs– Approval extended (IAFWA Project, UMESC)—

all fish eggs 6/18/98– Almost complete—all fish (UMESC)

Hydrogen peroxide (IAFWA Project)– Almost complete—all fish eggs (UMESC)– Almost complete—all fish (UMESC)

Work Underway—Fungicides (control Work Underway—Fungicides (control saprolegniasis) (continued)saprolegniasis) (continued)

Copper sulfate (IAFWA Project & sponsor)– Work underway (SNARC)

Potassium permanganate (IAFWA Project)– Possibility for development (SNARC)

Pyceze® (sponsor)– Work underway

Completed or Nearing CompletionCompleted or Nearing Completion—External parasiticides—External parasiticides

Copper sulfate (IAFWA Project and sponsor)– Ichthyophthirius—channel catfish in earthen ponds

(SNARC) Formalin—Approvals for certain fish & penaeid

shrimp—external protozoans– Approval extended (NRSP-7, IAFWA Project, &

UMESC)—all fish—external protozoans & monogenetic trematodes 6/18/98

Hydrogen peroxide (IAFWA Project)– External protozoans—salmonids (UMESC)

Sea lice controls– Slice®—Sponsor actively pursuing claim

Work Underway—External Work Underway—External parasiticides (continued)parasiticides (continued)

Potassium permanganate (IAFWA Project)– Ichthyophthirius—channel catfish in earthen ponds

(SNARC) Pyceze® (sponsor)

– Early development stage

Work Underway—Internal Work Underway—Internal ParasiticidesParasiticides

Myxozoan controls– Fumagillin

Whirling disease—trout (way underway by FWS, others) Proliferative gill disease—catfish (some work by

Mississippi State University)

Digenetic trematode or cestode controls– Praziquantel

Bolbophorus confusus in catfish (under consideration by sponsor)

STATUS OF EFFORTS STATUS OF EFFORTS TOWARD APPROVALS—TOWARD APPROVALS—OTHER AQUACULTURE OTHER AQUACULTURE

DRUGSDRUGS

Completed or Work Underway—Completed or Work Underway—Zero withdrawal AnestheticsZero withdrawal Anesthetics

AQUI-S™ (IAFWA Project and sponsor)—major effort underway by both entities– All freshwater-reared fish (AADAP & UMESC)– Saltwater salmonids (sponsor & IAFWA Project)

MS-222– Approved—several fish species but with 21-day

withdrawal time

Who Needs Zero Withdrawal Who Needs Zero Withdrawal Anesthetic?Anesthetic?

All private fish & shellfish aquaculture industries

All federal & state agencies involved in:– Fish & shellfish culture– Commercial & recreational fisheries– Fisheries & stock restoration– Threatened & endangered aquatic species

Completed or Work UnderwayCompleted or Work Underway—Spawning aids—Spawning aids

Human chorionic gonadotropin (many partners)– Approved—all fish 9/7/99

Crude carp pituitary (NRSP-7)– Almost complete but no possibility of product chemistry, so

LRP?

Ovaplant™ & Ovaprim™ (sponsor)– Work underway

ReproBoost™ (sponsor)– Work underway

Nearing Completion—Gender Nearing Completion—Gender Manipulation AidsManipulation Aids

17 alpha-methyltestosterone (sponsor & Auburn University)—tilapia & other species– Contract let for product chemistry data– Contract let for environmental safety data– Contract to be let for target animal safety—tilapia

Completed or Work Underway—Completed or Work Underway—Chemical Marking AidsChemical Marking Aids

Calcein (have sponsor)—work underwayOxytetracycline immersion (NRSP-7,

various partners including IAFWA Project)– Approved—all fish 12/24/03

Strontium chloride (have sponsor)—work underway through NRSP-7

FUTURE PLANSFUTURE PLANS

Future PlansFuture Plans

Develop data on all drugs in progress for initial or supplemental NADAs; complete goals of the IAFWA Project

Seek additional sponsors for additional drugs to gain initial or supplemental NADAs

Seek additional funding sources for aquaculture drug approval research