The U.S. Food and Drug Administration has announced it is making legally available a treatment for Ichthyophthirius multifiliis, also known as “Ich” or “white spot disease,” in ornamental finfish, including those commonly kept in home aquariums and outdoor hobby ponds.

The FDA is adding Faunamor to its Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, making it the only legal drug currently on the market to treat Ich. Faunamor is an antiparasitic and antimicrobial that contains three active ingredients: methylthionine chloride, malachite green oxalate and acriflavine chloride immersion solution.

Ich can affect many types of ornamental fish, including tropical fish, goldfish, and koi. The parasite that causes the disease can easily be introduced into a pond, tank, or home aquarium by adding new fish or equipment that has been moved from another unit holding infected fish. Ich is highly contagious and can spread rapidly from one fish to another. Ich outbreaks can kill all the fish in the tank, aquarium, or pond in a short time.

The most common sign of an Ich infection is the presence of small white spots on a fish’s skin or gills that can look like small blisters. Infected fish may also appear weak or lethargic and not want to eat.

Up to now, the only drugs available to treat Ich have been unapproved drugs that have not undergone FDA review for safety and effectiveness.

Through today’s addition, Faunamor joins FDA’s Index of new animal drugs intended for use in minor species (animals other than cattle, horses, swine, chickens, turkeys, dogs and cats) that have had their safety and effectiveness affirmed through an alternative FDA review process. In many cases, minor species drug products are intended for uses that cannot reasonably go through the standard drug approval process. They are often intended for use in species too rare or varied to be used in traditional safety and effectiveness studies. The Index is especially helpful to individuals treating animals or classes of animals representing markets too small to support the costs of the drug approval process.

As an alternative to the drug approval process for non-food producing minor species and non-food early life stages of food producing minor species, indexing provides a faster and less expensive process to obtain legal marketing status for eligible products.

As part of the FDA’s indexing process for animal drugs, a qualified expert panel evaluated the safety and effectiveness of Faunamor and determined that the benefits of using the drug outweigh its risks to ornamental finfish. FDA scientists reviewed the findings of the qualified expert panel and agreed with their conclusions before adding the drug to the Index. In addition, the drug company:

• demonstrated that the indexed product is safe to handle by the user when following labeling instructions;
• committed to following current Good Manufacturing Practices to preserve the drug’s identity, strength, quality and purity; and
• agreed to label, distribute, and promote Faunamor based on information in the index listing.

For as long as the drug company markets an indexed animal drug, the agency continues to monitor the drug’s safety and effectiveness; the manufacturing process to ensure that the identity, strength, quality, and purity of the drug are maintained; and the drug’s labeling to ensure the information remains truthful and not misleading.

Faunamor is available over the counter and is supplied in 20 mL and 100 mL (glass) bottles.

Faunamor is manufactured by Aquarium Münster Pahlsmeier GmbH based in Telgte, Germany.

For more information: 

• Freedom of Information Summary
• The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
• Drug Indexing
• Minor Use/Minor Species