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FDA Announces Approval of Uses for the Aquaculture Drug AQUAFLOR

News

June 4, 2012


The U.S. Food and Drug Administration (FDA) recently announced approval of a two new indications for the aquaculture drug, AQUAFLOR® (florfenicol) Type A Medicated Article, a product of Intervet, Inc. d/b/a Merck Animal Health, Summit, NJ. The approval marks the first transition of a conditionally approved drug to a fully approved product. Exponent Senior Managing Scientist Jane Staveley was the lead author of the Environmental Assessment that supported the approval.

AQUAFLOR® is now approved for use in all freshwater-reared finfish to control mortality due to columnaris disease, and in all freshwater-reared warmwater finfish to control mortality due to streptococcal septicemia; both diseases are associated with significant losses in U.S. aquaculture. AQUAFLOR®, a broad-spectrum in-feed antibiotic, was previously approved for several other indications in catfish and freshwater-reared salmonids.