FDA Issues an Announcement of the Availability of Safety and Effectiveness Data to Support a Minor Species New Animal Drug Application

July 1, 2011

The Food and Drug Administration (FDA) today is announcing the availability of a Public Master File (PMF) containing safety and effectiveness data to support a new animal drug application (NADA) or supplemental NADA for use of lincomycin hydrochloride water soluble powder for the control of American foulbrood (Paenibacillus larvae) in honey bees.

These data have been reviewed by FDA’s Center for Veterinary Medicine (CVM) and demonstrate the safety and effectiveness of this product. They may be used by pharmaceutical sponsors at no cost to support the approval of this product. Sponsors need to supply the additional manufacturing, labeling, and other required information to constitute a complete NADA. Today’s announcement is not for the approval of this product - only that data are available to support a pharmaceutical sponsor’s new animal drug application.

The data, contained in Public Master File (PMF) 5988, were compiled by the USDA’s Minor Use Animal Drug Program (formerly, the National Research Support Project 7 (NRSP–7)), a national research program that facilitates generation of data to support FDA approval of new drugs for minor uses and minor species of agricultural importance.