November 6, 2007
FDA Approves New Antimicrobial for Salmonids for Treatment of Furunculosis
The U.S. Food and Drug Administration (FDA) is announcing the approval of Aquaflor® (florfenicol) Type A medicated article for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida. Aquaflor® (florfenicol) is the first new antimicrobial approved for use during furunculosis outbreaks in more than 20 years.
Furunculosis is a serious salmonid pathogen in the United States which can appear as an acute septicemic infection in salmonid fish species. The disease causes significant losses of hatchery-reared salmonids, including loss at state and federal hatcheries producing fish for native species restoration programs.
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 Aquaflor® (florfenicol) are safe for human consumption when florfenicol is administered according to the label directions.
Aquaflor® is 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.
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®, as approved for furunculosis, 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; Donald.Prater@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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