Great News!!!  35% PEROX-AID® (hydrogen peroxide) was approved by the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine 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 associated with Flavobacterium branchiophilum, and (3) freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris). The broad use approval is unique and significant for U.S. aquaculture in that it covers two fish life stages (eggs and fish) of a number of cultured freshwater fish species for three separate disease indications. Left untreated, these diseases are responsible for annual losses in fish production that cripple public aquaculture in the U.S.

In contributing to this effort, USGS staff completed a comprehensive environmental assessment of hydrogen peroxide use in aquaculture, completed numerous animal safety studies on a broad variety of freshwater fish species, and conducted critical laboratory and field effectiveness studies. Eka Chemicals Inc., the drug sponsor, completed the requirements for drug manufacturing and worked with the National Coordinator for Aquaculture New Animal Drug Applications, Michigan State University to complete the requirements for human food safety and product labeling technical sections, provided additional information to support animal safety and effectiveness claims, and wrote the original New Animal Drug Application. All data were reviewed by the FDA to ensure the product met all necessary effectiveness, target animal safety, human food safety, and environmental safety standards. The FDA has concluded that fish treated with hydrogen peroxide are safe for human consumption when the fish are treated according to the approved label.

The announcement by the FDA for the approval of the new therapeutic drug (35% hydrogen peroxide) can be accessed through the following link:
http://www.fda.gov/cvm/CVM_Updates/perox-aid.htm.

For more information regarding USGS contributions to the approval contact Bill Gingerich, La Crossse, Wisconsin, 608.781.6225, bgingerich@usgs.gov.

Related links:

• William H. Gingerich Recognized by the Food and Drug Administration
  
  
• First New Waterborne Aquaculture Drug in 20 Years Approved
  
  

Dave Lovetro from Eka Chemicals recognizes researchers for contributions to the approval of 35% PEROX-AID®.