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AADAP: 25th Annual Drug Approval Coordination Workshop Recap

On July 31st, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) announced label extensions for 35% PEROX-AID for use in freshwater finfish!

Previously, 35% PEROX-AID was approved for the control of mortality in: (1) freshwater-reared finfish eggs due to Saprolegniasis; (2) freshwater-reared salmonids due to Bacterial Gill Disease (Flavobacterium branchiophilum); and (3) freshwater-reared coolwater finfish and channel catfish due to external columnaris disease (Flavobacterium columnare).

35% PEROX-AID is now also approved for: (1) controlling mortality in all coldwater finfish (including all salmonids), and all fingerling and adult freshwater-reared coolwater and warmwater finfish due to Saprolegniasis.  This will allow for the treatment of Saprolegniasis in life stages other than eggs; (2) controlling Gyrodactylus spp. in freshwater-reared salmonids; and (3) controlling mortality in all freshwater-reared warmwater finfish, including hybrid catfish and blue catfish, due to external columnaris (Flavobacterium columnare).

According to the FDA press release, “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.”