|Straus, David - Dave|
Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Research notes
Publication Acceptance Date: 10/18/2010
Publication Date: 11/17/2010
Citation: Bowker, J.D., Straus, D.L., Bowman, M.P., Carty, D., Dotson, M., Mitchell, A.J., Farmer, B.D. 2010. The Safety of AQUAFLOR (50% Florfenicol; Type A Medicated Article) Administered in feed to sunshine bass (female white bass Morone chrysops × male striped bass M. saxatilis). U.S. Fish & Wildlife Service, Aquatic Animal Drug Approval Partnership, Drug Research Information Bulletin 19. 2 p. Interpretive Summary:
Technical Abstract: Bacterial diseases are a major problem in aquaculture and account for significant losses of fish (Clarke and Scott 1989; Frerichs and Roberts 1989; Bjorndal 1990). Therefore, the use of antimicrobial therapy plays an important role in aquaculture (Klontz 1987; Alderman 1988). Florfenicol (FFC) is a potent, broad-spectrum, antibacterial agent with bacteriostatic and bacteriocidal properties that is active against a variety of Gram-positive and Gram-negative bacteria (Horsberg et al. 1996). AQUAFLOR® is an aquaculture feed premix containing 50% florfenicol (weight-to-weight). Worldwide, AQUAFLOR® has been approved in more than 20 countries (e.g., Norway, Japan, Chile, Canada, and the U.S.) to control mortality in a variety of cultured fishes due to diseases associated with infectious pathogens. In the U.S., the Food and Drug Administration (FDA) has approved AQUAFLOR® for use to control mortality in (1) catfish due to enteric septicemia associated with Edwardsiella ictaluri, (2) freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum, and (3) freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida (Bowker et al., in press). In the U.S., the only approved treatment regimen is to administer AQUAFLOR® in feed at 10 mg FFC/kg fish body weight/d for 10 consecutive days.