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FDA Reminder for Approved Aquatic Drugs

The U.S. Food and Drug Administration (FDA) wants to remind you that not all drugs currently marketed for fish are approved.  And even if a marketed product has the same established name (active ingredient) as an FDA-approved drug, that doesn’t mean it’s also FDA-approved.

Please see the table below for a list of all FDA-approved fish drugs.  If a product currently marketed for fish isn't listed, it's not FDA-approved, and therefore, hasn’t been shown to be safe and effective in fish.  For example, only the four listed formalin products are approved by FDA for fish.  Any other formalin-containing products marketed are not FDA-approved.

FDA rigorously evaluates an animal drug before approving it.  As part of the approval process, the drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species. For food fish intended for human consumption, the drug company must also prove that food made from fish treated with the drug is safe for people to eat;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and complete.

FDA’s role doesn’t stop after the agency approves an animal drug.  As long as the drug company markets the animal drug, the agency continues to monitor the drug’s:

  • Safety and effectiveness to determine if concerns arise that were unknown at the time of approval;
  • Manufacturing process to ensure quality and consistency are maintained; and
  • Labeling to make sure the information remains truthful and complete.

FDA-Approved Fish Drugs

Trade Name (established name)1

Application Type & Number

Formalin-F™
(formalin)

NADA2 137-687

Formacide-B
(formalin)

ANADA3 200-414

Paracide-F
(formalin)

NADA 140-831

Parasite-S
(formalin)

NADA 140-989

35% Perox-aid
(hydrogen peroxide)

NADA 141-255

OxyMarine™
(oxytetracycline hydrochloride)

NADA 130-435

Oxytetracycline HCl Soluble Powder-343
(oxytetracycline hydrochloride)

ANADA 200-247

Pennox 343
(oxytetracycline hydrochloride)

ANADA 200-026

Terramycin-343 Soluble Powder
(oxytetracycline hydrochloride)

NADA 008-622

Tetroxy Aquatic
(oxytetracycline hydrochloride)

ANADA 200-460

Finquel
(tricaine methanesulfonate)

NADA 042-427

Tricaine-S
(tricaine methanesulfonate)

ANADA 200-226

Chorulon®
(chorionic gonadotropin)

NADA 140-927

Aquaflor® Type A Medicated Article
(florfenicol)

NADA 141-246

Terramycin® 200 for Fish
(oxytetracycline dihydrate)

NADA 038-439

Romet®-30
(sulfadimethoxine & ormetoprim)

NADA 125-933

Sulfamerazine In Fish Grade
(sulfamerazine)

NADA 033-950

1The drug’s established name is the active ingredient.
2NADA – New Animal Drug Application1.
3ANADA – Abbreviated New Animal Drug Application2 for a generic animal drug.
More information about approved drugs for aquaculture3.

FDA-approved animal drugs are scientifically shown to be safe and effective when used according to the directions on the label. If the approved drugs are for food fish, food made from treated fish is safe for people to eat.  FDA-approved animal drugs also meet the agency’s strict standards for quality, purity, and potency.

The Center for Veterinary Medicine (CVM) at FDA is responsible for ensuring that safe and effective drugs are available for animals. If you have questions or would like more information, please call the CVM Communications Staff at 240-276-9300, or email us at AskCVM@fda.hhs.gov.

 

 

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