July 26, 2019

The U.S. Food and Drug Administration’s Center for Veterinary Medicine announced today the approval of additional indications for 35% PEROX-AID for use in freshwater finfish. This approval will help provide a critical treatment for improving fish health. The agency also anticipates that resource management agencies will use this approved treatment for aiding in the restoration of certain freshwater fish populations.

35% PEROX-AID was previously approved for the control of mortality in: (1) freshwater-reared finfish eggs due to saprolegniasis, a fungal disease that can cause lesions on the fish’s skin, and in some cases, cause respiratory distress and death; (2) freshwater-reared salmonids due to bacterial gill disease; and (3) freshwater-reared coolwater finfish and channel catfish due to external columnaris disease, a common and often fatal disease for fish that is caused by bacteria in water that can enter a fish’s mouth, gills or a wound.

35% PEROX-AID is now also approved for:

• the control of mortality in freshwater-reared coldwater finfish, fingerling and adult freshwater-reared coolwater finfish, and fingerling and adult freshwater-reared warmwater finfish due to saprolegniasis. This indication allows for the treatment of saprolegniasis in life stages other than eggs; 
• the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids. Gyrodactylus spp. are external parasites of fish, making 35% PEROX-AID a new option for treating parasites on fish; and 
• the control of mortality due to external columnaris in all freshwater-reared warmwater finfish, in addition to the previously approved indication for freshwater-reared coolwater finfish and channel catfish.

In a recent survey conducted by the U.S. Fish and Wildlife Service, Association of Fish and Wildlife Agencies, and National Aquaculture Association, these diseases were identified as top disease concerns for fish. While these diseases can be harmful to fish, they do not affect people.

Studies to demonstrate effectiveness for the new indications were conducted by the U.S. Fish and Wildlife Service’s Aquatic Animal Drug Approval Partnership program, the U.S. Geological Service’s Upper Midwest Environmental Science Center, and the Food and Drug Administration Center for Veterinary Medicine’s Office of Research.

These studies showed that mortality associated with two different species of Saprolegnia was controlled in three different species of fish: rainbow trout, walleye, and channel catfish. Four field studies demonstrated the effectiveness of 35% PEROX-AID for the treatment of Gyrodactylus spp. infestations in freshwater-reared salmonids, and two additional clinical field trials were conducted in largemouth bass and bluegill to extend the indication of control of mortality due to external columnaris disease to freshwater-reared warmwater finfish.

In addition, data demonstrate that food products derived from species treated with 35% PEROX-AID are safe to eat when the product is used in accordance with the labeling.

People administering 35% PEROX-AID should avoid eye and skin contact; breathing vapor or mist from the product; and swallowing the product. The labeling indicates that people administering 35% PEROX-AID to fish should wear chemical safety goggles; neoprene, butyl, or vinyl gloves; and suitable protective clothing. 

35% PEROX-AID is available over-the-counter in 5-gallon containers (19L), 55-gallon drums (208L), and 328-gallon containers (1240L). Syndel USA received the approval for 35% PEROX-AID.

This approval is important in that it provides an FDA-approved drug for additional indications in a significant number of minor species. “Minor species” include fish. Some fish are of agricultural importance, including catfish, trout and salmon.

This approval furthers the FDA’s commitment to ensuring safe and effective animal drugs are available for a wide range of diverse animal species. The FDA’s Minor Use and Minor Species program aims to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in the major animal species. The program provides innovative ways to bring products to market for these small populations as well as incentives designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs.

For more information:

• Freedom of Information Summary for the Supplemental Approval of 35% PEROX-AID
• Freedom of Information Summary for the Original Approval of 35% PEROX-AID
• FDA’s Office of Minor Use and Minor Species
• FDA’s Aquaculture Webpage