April 20, 2009
FDA Issues a Notice of the Availability of Effectiveness Data to Support a New Animal Drug Application for Fish
The Food and Drug Administration (FDA) is announcing the availability of a Public Master File (PMF) containing effectiveness data for use of oxytetracycline quaternary salt in feed for two indications: to control mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum and to control mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare.
The data have been reviewed by FDA’s Center for Veterinary Medicine (CVM) and may be used by pharmaceutical sponsors at no cost, along with the additional manufacturing, labeling, and other required information to constitute a complete new animal drug application (NADA), to support the approval of this drug. Today’s announcement is not for the approval of this drug - only that effectiveness data are available to support a pharmaceutical sponsor’s new animal drug application for this drug.
The data, contained in Public Master File (PMF) 5927, was compiled by researchers at the Aquatic Animal Drug Approval Partnership Program http://www.fws.gov/fisheries/aadap/home.htm, a partnership-based program to conserve, protect, and enhance the Nation’s fishery resources by coordinating activities to obtain FDA approval for drugs needed in aquaculture and fisheries management programs.
For additional information on aquaculture, please see http://www.fda.gov/cvm/aqualibtoc.htm.
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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