NRSP-7’s Western and Central Regions would like to draw attention to the fact that their work in developing data for the eventual approval of the progesterone CIDR intravaginal insert for induction of estrus in sheep has been published as a Public Master File [PMF] by FDA. A PMF making the data available has just been announced by FDA [http://www.fda.gov/cvm/MSNADASafetyNotice.htm]. The next part of the process will be for a manufacturer, who has access to the product’s toxicological data, and the manufacturing information for the drug, to use these data to apply for a new animal drug approval from FDA. In this case Pfizer owns exclusive U.S. marketing rights for this product, so they will be the only sponsor able to use these data at this time. Interested sheep producers should follow this and Pfizer’s web sites for news on when the CIDRs will be available.
NRSP-7 especially wants to acknowledge the work of Drs. Keith Inskeep of West Virginia University, Dennis Hallford of New Mexico State University, and Joan Rowe of the University of California, Davis. in this project.
The CVM website has an update at http://www.fda.gov/cvm/CVM_Updates/MSNADASafetyNotice.htm
