AQUAFLOR is the first in-feed antibiotic in aquaculture and the second for all food-animal species to be classified by the FDA as a Veterinary Feed Directive (VFD) drug. VFD is a category established in 1996 to help the agency more closely control new therapeutic products, primarily antimicrobials, and their use in food animals. The VFD classification applies only to new in-feed therapeutics approved by FDA after 2000. Fish farmers may obtain VFD drugs through normal feed distribution channels, but they will require a signed Veterinary Feed Directive from a licensed veterinarian.
AQUAFLOR® (florfenicol) has new label indications in the United States permitting its use in all freshwater-reared finfish. According to Palma Jordan, global marketing director for aquatic animal health products at Merck Animal Health (known as MSD Animal Health outside the United States and Canada), “the new claims for AQUAFLOR in the United States reflect the company’s ongoing global effort to develop products for aquaculture.”
The major changes to the AQUAFLOR label in the United States include:
AQUAFLOR can now be used in tilapia, striped bass, catfish, trout, and all other freshwater-reared finfish at 10 to 15 mg/kg bodyweight per day for the control of mortality due to columnaris disease associated with Flavobacterium columnare.
AQUAFLOR is approved for use in all freshwater-reared warmwater finfish at 15 mg/kg for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae, an organism known to cause significant economic losses in farm-raised tilapia and some other species.
AQUAFLOR now has a single withdrawal period of 15 days for all finfishspecies treated at dose rates of 10 to 15 mg/kg.