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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Approval of New Antimicrobial for Salmonids

March 22, 2007

The U.S. Food and Drug Administration is announcing the approval of Aquaflor® (florfenicol) Type A medicated article for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum. Aquaflor® (florfenicol) is the first drug approved by the 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. The agent, F. psychrophilum, is a serious salmonid pathogen in the United States. The disease causes significant losses of hatchery-reared salmonids, including loss at state and federal hatcheries producing fish for native species restoration programs. Up to 50% of affected fish may be lost during disease outbreaks, with greater mortality in younger fish.

FDA reviewed extensive data to ensure 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.

Aquaflor® is defined as a Veterinary Feed Directive drug, which means that the medicated feed can only be fed on the order of a licensed veterinarian. The extra-label or off label use of medicated feed containing florfenicol is not allowed.

As part of the human food safety requirements, Aquaflor® was reviewed under the Center for Veterinary Medicine’s Guidance for Industry #152 "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern." GFI #152 provides a regulatory pathway sponsors can use to show how an antimicrobial drug can be used in food-producing animals without endangering public health.

The approval of Aquaflor® is the result of cooperation between the pharmaceutical company, Schering-Plough Animal Health Corp., and public sector researchers. The following government groups generated and contributed data for the approval: the Fish and Wildlife Service, Aquatic Animal Drug Approval Partnership Program, Bozeman, Montana; U. S. Geologic Survey, Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin; and the Montana Department of Fish, Wildlife, and Parks.

Aquaflor® is a product of Schering-Plough Animal Health Corporation, Summit, New Jersey. Aquaflor® is designated under the Minor Use and Minor Species Act of 2004, which entitles Schering-Plough Animal Health Corporation to seven years of exclusive marketing rights beginning on the date of approval.

Additional information on this approval may be obtained by contacting Dr. Donald Prater, Division of Therapeutic Drugs for Food Animals, FDA, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV-131, Rockville, MD 20855, 301-827-7567; E-mail: Donald.Prater@fda.hhs.gov

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855