FDA Indexes New Drug for Ornamental Finfish Parasites

March 6, 2026

The U.S. Food and Drug Administration recently added Prazi-Med (praziquantel powder for immersion) to The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Prazi-Med is for the treatment of internal parasites (flukes and tapeworms) and external parasites (flukes) susceptible to praziquantel in ornamental finfish (except Callichthyidae and Cleriidae catfish), including those commonly kept in home aquariums and outdoor hobby ponds. This is the first indexed praziquantel product for use in fish.

Compared to the new animal drug approval process, indexing provides a faster and less expensive pathway to obtain legal marketing status for eligible products. Animal drugs in the Index (‘indexed drugs’) are intended for use in non-food producing minor species and non-food early life stages of food-producing minor species. Minor species are animals other than cattle, horses, swine, chickens, turkeys, dogs and cats.

In many cases, animal drug products intended for use in minor species cannot practically go through the standard new animal drug approval process. These drugs 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 in markets too small to support the costs of the new animal drug approval process.

As part of the FDA’s indexing process for animal drugs, a qualified expert panel evaluates the safety and effectiveness of a drug to determine that the benefits of using the drug outweigh its risks to the animal. Before adding a drug to the Index, FDA scientists must review the findings of the qualified expert panel and agree with their conclusions. In addition to other requirements, the drug company must:

• demonstrate that the indexed product is safe to handle by the user when following labeling instructions;
• commit to following current Good Manufacturing Practices to preserve the drug’s identity, strength, quality and purity; and
• commit to label, distribute, and promote the drug based on information in the index listing. For as long as the drug company markets an indexed animal drug, the FDA continues to monitor 1) the drug’s safety and effectiveness; 2) the manufacturing process to ensure that the identity, strength, quality, and purity of the drug are maintained; and 3) the drug’s labeling to ensure the information remains truthful and not misleading.

Prazi-Med is available over the counter for use only in personal home aquariums, personal home ponds, or public aquariums and zoos. The drug is supplied in 50 g and 250 g plastic bottles and 10 g mylar packets.

Prazi-Med is manufactured by Aqion, LLC based in Dallas, Texas.

For more information:

• Freedom of Information Summary – Prazi-Med (MIF 900-054)
• The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
• Drug Indexing

• Minor Use/Minor Species

• Content current as of:

03/18/2026

• Regulated Product(s)

  • Animal & Veterinary