Major U.S. Aquaculture Drug Approval for 35% PEROX-AID

Frst new waterborne drug approved for a disease claim for any aquatic species in more than 20 years, second aquaculture drug to gain designation under the MUMS and first new aquaculture drug with an original approval covering multiple label claims for use in a variety of finfish species

January 18, 2007

Major Aquaculture Drug Approval for 35% PEROX-AID®

35% PEROX-AID® (hydrogen peroxide) was approved on January 11, 2007 for control of mortality in (1) freshwater-reared finfish eggs due to saprolegniasis, (2) freshwater-reared salmonids due to bacterial gill disease, and (3) freshwater-reared coolwater finfish and channel catfish due to external columnaris disease.

Eka Chemicals, Inc. (Marietta, Georgia), is the sponsor of 35% PEROX-AID®. This is a very important approval because it is the first new waterborne drug approved for a disease claim for any aquatic species in more than twenty years and the second aquaculture drug to gain designation under the Minor Use and Minor Species Animal Health Act, which entitles Eka Chemicals, Inc. to seven years of exclusivity for marketing rights for the approved label claims, and is the first new aquaculture drug with an original approval covering multiple label claims for use in a variety of finfish species

Various entities played a role in this significant achievement. The Upper Midwest Environmental Sciences Center (UMESC; U.S. Geological Survey, La Crosse, Wisconsin) developed the data that resulted in the approval for these label claims and did this with financial support through base funds and the Federal-State Aquaculture Drug Approval Partnership Project. UMESC (1) wrote the environmental assessment that completed the environmental safety requirements, (2) performed target animal safety studies on representative species and their eggs so that all freshwater-reared finfish and their eggs could be placed on this or future labels, and (3) conducted laboratory and field effectiveness studies that resulted in these label claims being approved. Eka Chemicals, Inc. completed the requirements for manufacturing and worked together with the National Coordinator for Aquaculture New Animal Drug Applications to (1) complete the requirements for human food safety, labeling, and all other information on safety and effectiveness and (2) write the original New Animal Drug Application.

35%PEROX-AID® is approved with over-the-counter marketing status and has no requirement for an acceptable daily intake, tolerance, withdrawal time, or regulatory method. Eka Chemicals Inc. has licensed Western Chemical Inc. (telephone: 800-283-5292 or 360-384-5898; address: 1269 Lattimore Road, Ferndale, WA 98248-9424) as the sole distributor of 35%PEROX-AID®.

FDA Center for Veterinary Medicine has indicated that the Low Regulatory Priority Drug status for hydrogen peroxide is rescinded. Formerly, facilities could purchase and use most any brand of hydrogen peroxide that was consistent with FDA’s policy. This has changed and the ONLY hydrogen peroxide product that can legally be purchased and used is 35%PEROX-AID® and it is for the approved label claims.

To use 35%PEROX-AID® to treat additional diseases or additional species not covered on the current label, licensed veterinarians may be able to prescribe a legal extra-label use.