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FDA-Approved Drugs for Aquaculture Use in the US (2019)

FDA-Approved Drugs for Aquaculture Use in the US (2019)

Drug

Species

Indications

Dosage Regimen

Comments

Immersion

Formalin

All finfish

Control external protozoa (Chilodonella, Ichthyobodo, Epistylis, Ichthyophthirius, Ambiphyra, Trichodina spp), Tetrahymena spp and monogeneans (Cleidodiscus, Dactylogyrus, Gyrodactylus spp)

Tanks and raceways: salmon and trout: >10°C (50°F): up to 170 μL/L for up to 1 hour; < 10°C (50°F): up to 250 μL/L for up to 1 hour. All other finfish: up to 250 μL/L for up to 1 hour

Earthen ponds: 15–25 μL/L indefinitely

Drug must not be subjected to temperature <4.44°C (40°F). Do not apply to ponds when water is >26.67°C (80°F), there is a heavy phytoplankton bloom, or dissolved oxygen concentration is <5 mg/L. Ponds may be re-treated in 5–10 days if needed. Do not treat ponds containing striped bass. Test on a small number from each lot to check for any unusual sensitivity to formalin before proceeding.

All finfish eggs

Control water molds of the family Saprolegniaceae

All finfish eggs: 1,000–2,000 mcL/mL for 15 minutes

Acipenseriformes: up to 1,500 mcL/mL for 15 minutes

Preliminary bioassay should be conducted to determine species sensitivity.

Penaeid shrimp

Control protozoan parasites (Bodo, Epistylis, and Zoothamnium spp)

Tanks and raceways: 50–100 mcL/L for up to 4 hours daily

Earthen ponds: 25 mcL/L as single treatment

Drug must not be subjected to temperature <4.44°C (40°F). Do not apply to ponds when water is >26.67°C (80°F), when there is a heavy phytoplankton bloom, or when dissolved oxygen concentration is <5 mg/L. Ponds may be re-treated in 5–10 days if needed.

Hydrogen peroxide

Freshwater-reared finfish eggs

Control mortality due to saprolegniasis

Coldwater and coolwater: 500–1,000 mg/L for 15 minutes in a continuous flow system daily on consecutive or alternate days until hatch

Warmwater: 750–1,000 mg/L for 15 minutes in a continuous flow system daily on consecutive or alternative days until hatch

Initial bioassay on a small number is recommended before treating entire group.

Freshwater-reared salmonids

Control mortality due to bacterial gill disease (Flavobacterium branchiophilum)

100 mg/L (30 minutes) or 50–100 mg/L (60 minutes) daily on alternate days for 3 treatments

Initial bioassay on a small number is recommended before treating entire group.

Freshwater-reared coolwater finfish and channel catfish

Control mortality due to external columnaris disease (Flavobacterium columnare)

Fingerling and adults (except northern pike and paddlefish): 50–75 mg/L (60 minutes) daily on alternate days for 3 treatments

Fry (except northern pike, pallid sturgeon, and paddlefish): 50 mg/L (60 minutes) daily on alternate days for 3 treatments

Use with caution on walleye.

Initial bioassay on a small number is recommended before treating entire group.

Oxytetracycline hydrochloride

Finfish fry and fingerlings

Mark skeletal tissues, most often otoliths, of finfish fry and fingerlings for identification purposes

200–700 mg/L (buffered) for 2–6 hours

Tricaine methanesulfonate

Fish, amphibians, and other aquatic poikilotherms

Temporary immobilization

15–330 mg/L (fish)

1:1,000 to 1:20,000 (other poikilotherms)

Powder is added to water; concentration depends on desired degree of anesthesia, species, size, water temperature and softness, stage of development.

Preliminary tests of solution should be made with a few fish; 21-day withdrawal time (fish); laboratory or hatchery use only in other poikilotherms; water temperature >50°F (10°C)

Chloramine-T

Freshwater-reared salmonids

Bacterial gill disease caused by Flavobacterium spp.

12 to 20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments.

Walleye

External columnaris disease caused by Flavobacterium columnare

10 to 20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments.

Freshwater-reared warmwater finfish

External columnaris caused by Flavobacterium columnare

20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments.

Injectable

Chorionic gonadotropin

Male and female brood finfish

Help improve spawning function

Males: 110–1122 U/kg

Females: 147.4–3995.2 U/kg

IM injection up to 3 doses; total dose not to exceed 25,000 U in fish intended for human consumption; restricted to use by or on the order of a licensed veterinarian

Medicated Article/Feed

Florfenicol

Freshwater-reared finfish

Control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri, streptococcal septicemia in freshwater-reared warmwater finfish, columnaris disease in freshwater-reared finfish

10 mg/kg/day for 10 consecutive days

Veterinary Feed Directive drug; 12-day withdrawal time

Oxytetracycline dihydrate

Pacific salmon

Mark skeletal tissue, most often otoliths, of finfish fry and fingerlings for identification purposes

250 mg/kg/day for 4 days

Veterinary Feed Directive drug; salmon <30 g; in feed as sole ration; 7-day withdrawal time

Freshwater-reared salmonids

Bacterial coldwater disease (Flavobacterium psychrophilum)

2.5–3.75 g/100 lb/day for 10 days

Veterinary Feed Directive drug; in mixed ration; water temperature not <9°C (48.2°F); 21-day withdrawal time

Cool freshwater-reared finfish

Control bacterial hemorrhagic septicemia (Aeromonas liquefaciens, furunculosis (Aeromonas salmonicida), and pseudomonas disease (Pseudomonas)

2.5–3.75 g/100 lb/day for 10 days

Veterinary Feed Directive drug; in mixed ration; water temperature not <16.7°C (62°F); 21-day withdrawal time

Lobster

Control gaffkemia (Aeroccocus viridans)

1 g/lb medicated feed for 5 days

Veterinary Feed Directive drug; in feed as sole ration; 30-day withdrawal time

All freshwater-reared Pacific salmon

Control of columnaris disease

Veterinary Feed Directive drug, only allowed in feed; 21-day withdrawal time.

Sulfadimethoxine-ormetoprim

Salmonids

Control furunculosis (Aeromonas salmonicida)

50 mg/kg/day for 5 days

Veterinary Feed Directive drug; in feed; 42-day withdrawal time

Catfish

Control enteric septicemia (Edwardsiella ictaluri)

50 mg/kg/day for 5 days

Veterinary Feed Directive drug; only allowed in feed; 3-day withdrawal time

Note: This is an abbreviated summary. For more information visit the FDA website (https://www.fda.gov/animal-veterinary/aquaculture/approved-aquaculture-drugs). For complete labeling, see the package insert. Approval applies only to the specific drug that is the subject of a new animal drug application (NADA); active ingredients from other sources (eg, a bulk drug from a chemical company or similar compounds made by companies other than those specified in the NADA) are not approved new animal drugs. Approval applies only to use of the drug for the indications and manner specified on the label. The Aquatic Animal Drug Approval Partnership (AADAP) has several helpful publications on FDA-approved drugs.