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U.S. Department of Health and Human Services

Animal & Veterinary

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Antimicrobial OK’d to Control Coldwater Disease Mortality in Salmonids

FDA Veterinarian Newsletter 2007 Volume XXII, No I

The Food and Drug Administration recently approved AQUAFLOR® (florfenicol) Type A medicated article for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.

AQUAFLOR® is the first drug approved by FDA for use during coldwater disease outbreaks. The drug is an important disease management tool for aquaculture and fisheries programs.

Coldwater disease is an acute septicemic infection occurring primarily in salmonid fish species. F. psychrophilum, the causative agent, is considered a serious salmonid pathogen in the United States. The disease causes significant losses of hatchery-reared salmonids, including losses at state and federal hatcheries producing fish for native species restoration programs. Up to 50 percent of affected fish may be lost during disease outbreaks, with greater mortality in younger fish.

FDA approved the product as a Veterinary Feed Directive drug, meaning that the medicated feed can be fed only on the order of a licensed veterinarian. Extralabel use of medicated feed containing florfenicol is prohibited.

AQUAFLOR® for the approved label indication is designated under the Minor Use and Minor Species Act of 2004, which entitles Schering-Plough Animal Health Corporation up to 7 years of exclusive marketing rights beginning on the date of approval.

This approval is the result of cooperation between a pharmaceutical company, Schering-Plough Animal Health Corp., Summit, NJ, and public sector researchers. The Fish and Wildlife Service, Aquatic Animal Drug Approval Partnership Program, Bozeman, MT; U.S. Geologic Survey, Upper Midwest Environmental Sciences Center, La Crosse, WI; and the Montana Department of Fish, Wildlife, and Parks generated data for the approval.

FDA reviewed extensive data to make sure the product met all necessary effectiveness, target animal safety, human food safety, and environmental safety standards. FDA has concluded that freshwater-reared salmonids fed florfenicol are safe for human consumption when florfenicol is administered according to the label directions.

As part of the human food safety requirements, AQUAFLOR® was reviewed under the Center for Veterinary Medicine’s Guidance for Industry, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The Guidance provides a regulatory pathway sponsors can use to show how an antimicrobial drug can be used in food-producing animals without endangering public health. CVM has determined that antimicrobial resistance risk management strategies (as described in the Guidance) in place for AQUAFLOR® are appropriate for its conditions for use.