October 25, 2005
FDA Approves New Antimicrobial for Catfish
The U.S. Food and Drug Administration has approved AquaflorŽ Type A Medicated Article (florfenicol), an antimicrobial for the control of mortality due to enteric septicemia of catfish (New Animal Drug Application 141-246). Enteric septicemia of catfish, a bacterial disease, is one of the most serious diseases of farm-raised catfish. The disease results in significant economic losses to the catfish industry.
AquaflorŽ, a product of Schering-Plough Animal Health Corporation, Union, New Jersey, is the first new antimicrobial approved for finfish in over two decades. The product is the second approved Veterinary Feed Directive (VFD) drug meaning that the medicated feed can only be fed on the order of a licensed veterinarian. Extra-label use of medicated feed containing florfenicol is prohibited by regulation.
AquaflorŽ for the approved indication was the first drug designated under the Minor Use and Minor Species Animal Health Act. This entitles Schering-Plough Animal Health Corporation to seven years of exclusive marketing rights for the approved indication beginning on the date of approval.
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 catfish fed florfenicol are safe for human consumption when the fish are treated according to the approved label.
AquaflorŽ was also 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." The safe use of antimicrobials in the production of food-producing animals is an important public health issue. GFI #152 provides a regulatory pathway sponsors can use to show how a new antimicrobial drug can be used in a food-producing animal without endangering public health. CVM has determined that antimicrobial resistance risk management strategies (as described in GFI #152) in place for AquaflorŽ are appropriate for its proposed conditions of use.
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.gov.
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