March 20, 2009
FDA Issues a Notice of the Availability of Safety and Effectiveness Data to Support a Minor Species New Animal Drug Application
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 the progesterone insert (CIDR) for induction of estrus in ewes (sheep) during seasonal anestrous.
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 along with 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) 5947, were compiled by researchers at the National Research Support Project 7 (NRSP–7) http://www.nrsp-7.org/welcome.htm, a national agricultural research program that facilitates generation of data to support FDA approval of new drugs for minor animal species and for minor uses in the major species.
FDA is providing the data in advance of the Federal Register publication in order to make the information available to potential sponsors as quickly as possible. Please see the Notice of Availability at http://www.fda.gov/cvm/CIDR032009.htm.
For additional information on animal drugs for minor uses and minor species, please see http://www.fda.gov/cvm/minortoc.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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