Rockville, Md. — The U.S. Food and Drug Administration (FDA) greenlights the use of Terramycin® 200 for Fish (oxytetracycline dihydrate) Type A medicated article to control mortality in freshwater-reared salmon, trout and whitefish.
The new indications, announced yesterday, were issued to treat coldwater disease caused by the bacterial pathogen Flavobacterium psychrophilum and control mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare. The approval also allows for removal of temperature limitation on previous approved salmonid indications, which restricted its use to water temperatures more than 48.2 degrees.
The regulatory agency says it reviewed "extensive data" to ensure the products met safety and efficacy standards.
Terramycin® 200 for Fish is manufactured by Phibro Animal Health in Ridgefield Park, N.J. It is designated for use under the Minor Use and Minor Species Act Animal Health Act of 2004, which gives Phibro Animal Health seven years of exclusive marketing rights.
For more information, contact 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. He can be reached at (240) 276-8343 or Donald.Prater@fda.hhs.gov.