October 25, 2005
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) (http://www.fda.gov/cvm/vfd.html) 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 (http://www.fda.gov/cvm/minortoc.htm)
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 Medicines
Guidance for Industry #152 (http://www.fda.gov/cvm/Guidance/fguide152.pdf
- 36 pages) "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.
Source: http://www.fda.gov/cvm/CVM_Updates/catfishapp.htm
Pamela Tom
University of California
Sea Grant Extension Program
Web: http://seafood.ucdavis.edu
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