AQUAFLOR Now Labeled in the United States for All Freshwater-reared Finfish


13 April 2012
Boxmeer (The Netherlands)

BOXMEER, The Netherlands, April 13, 2012 —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 withFlavobacterium 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 withStreptococcus 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 finfish species treated at dose rates of 10 to 15 mg/kg.

The new claims approved by the U.S. Food and Drug Administration give AQUAFLOR the broadest range of approved fish species and indications of any aquatic animal health antibiotic used in the United States. The new indications are also exclusive to the AQUAFLOR brand of florfenicol.

Merck Animal Health emphasized that the new withdrawal time was established to facilitate compliance across all species and dose rates without any change in the high safety profile of AQUAFLOR. AQUAFLOR was developed specifically for aquaculture use; its active ingredient – florfenicol - is not used in human medicine.

As before, AQUAFLOR is also approved in the United States for the control of mortality due to enteric septicemia (ESC) associated withEdwardsiella ictaluriin catfish, as well as for the control of mortality due to furunculosis associated withAeromonas salmonicidaand coldwater disease associated withFlavobacterium psychrophilumin freshwater-reared salmonids.

AQUAFLOR, which can be top-coated or incorporated in both floating and sinking feeds, has been shown to be highly stable following high-temperature extrusion at feed mills. It is also highly palatable, which helps to optimize antibiotic intake. AQUAFLOR medicated feed should be administered as the sole ration for 10 consecutive days. AQUAFLOR is not approved for use in breeding stock or for use in recirculating aquaculture systems.

For more information about AQUAFLOR and/or product claims outside the U.S., producers outside of the United States should contact their veterinarian, diagnostician, feed company, Merck Animal Health representative or go towww.merck-animal-health.com. In the United States, information is also available atwww.aquaflor-usa.com. Producers should always consult the label for indications approved in their local market.