USA - 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 florfenicol in feed for three indications:  to control mortality due to coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonids; to control mortality due to furunculosis associated with Aeromonas salmonicida in freshwater-reared salmonids, and to control mortality due to streptococcal septicemia associated with Streptococcus iniae in hybrid striped bass (Morone chrysops x M. saxatilis).

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) 005932, were compiled by researchers at the Aquatic Animal Drug Approval Partnership Program (AADAP) 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 FDA information on aquaculture please see: http://www.fda.gov/cvm/aqualibtoc.htm.