FDA Issues Data to Support a New Drug Application

The Food and Drug Administration (FDA) this week announced the availability of effectiveness, target animal safety, human food safety and environmental safety data that may be used in the support of a new animal drug application (NADA) or supplemental NADA for the use of the progesterone insert (CIDR) for induction of estrus in ewes during seasonal anestrous.

The data, contained in Public Master File (PMF) 5947, were compiled by researchers at the National Research Support Project 7, a national agricultural research program that facilitates generations of data to support FDA approval of new drugs for minor animal species and for minor uses in the major species.

CIDR for induction of estrus in ewes during seasonal anestrous is a new animal drug under the Federal Food, Drug and Cosmetic Act. As a new animal drug, the uses of progesterone are subject to the approval of a NADA or supplemental NADA. Sheep are a minor species under the act.

For further information, contact Linda Wilmot at 240-276-8101 or linda.wilmot@fda.hhs.gov. 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. The notice of availability can be accessed at www.fda.gov/cvm/CIDR032009.htm.