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July
11, 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
48.2ºF
(9ºC).
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 14ºC.
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.
Provided
by AquaVetMed
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