July 10, 2008
FDA Approves Antimicrobial for Two New Aquaculture Indications
The U.S. Food and Drug Administration (FDA) has approved Terramycin® 200 for Fish (oxytetracycline dihydrate) Type A medicated article for the control of mortality in freshwater-reared salmonids due to coldwater disease caused by Flavobacterium psychrophilum and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare (New Animal Drug Application 038-439). In addition to these two new indications, the approval allows for removal of the temperature limitation on previously approved salmonid indications, which restricted its use to water temperatures above 48.2 oF (9 oC).
Terramycin® 200 for Fish is the second drug approved for use during outbreaks of coldwater disease. Untreated, this disease can cause significant losses among salmonids at state and federal hatcheries including native species in restoration programs.
Terramycin® 200 for Fish is the first drug approved for the control of mortality due to systemic columnaris disease associated with Flavobacterium columnare in freshwater-reared Oncorhynchus mykiss. Oncorhynchus mykiss includes rainbow, steelhead, and redband trout, as well as other related subspecies. Columnaris can be a problem for trout and other fish when water temperatures are above 14 oC.
FDA reviewed extensive data to ensure the product met all necessary effectiveness, target animal safety, human food safety, and environmental safety standards. As part of the human food safety requirements, Terramycin® 200 for Fish was reviewed under the Center for Veterinary Medicine’s Guidance for Industry #152 “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” GFI #152 provides a regulatory pathway sponsors can use to show how any antimicrobial resistance risks associated with the use of an antimicrobial drug in food-producing animals can be managed without endangering public health. FDA has concluded that fish fed oxytetracycline are safe for human consumption when the drug is administered according to the approved label directions.
Terramycin® 200 for Fish is a product of Phibro Animal Health, Ridgefield Park, New Jersey. The drug, as approved for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare, is designated under the Minor Use and Minor Species Animal Health Act of 2004, which entitles Phibro Animal Health to seven years of exclusive marketing rights beginning on the date of approval.
This supplemental approval is the result of cooperation between the pharmaceutical company, Phibro Animal Health, and public sector researchers, the U.S. Fish and Wildlife Service’s Aquaculture Animal Drug Approval Partnership Program and the U.S. Geological Survey’s Upper Midwest Environmental Science Center.
Additional information on this approval may be obtained by contacting Dr. Donald A. 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, 240-276-8343, Donald.Prater@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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