FDA Issues Notice of the Availability of Effectiveness Data to Support a New Animal Drug Application for Fish
The United States Food and Drug Administration (FDA) has announced 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, 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.