WASHINGTON — The Food and Drug Administration approved EAZI-Breed Controlled Intravaginal Drug Release Sheep Insert (progesterone solid matrix) for induction of estrus in ewes (sheep) during seasonal anestrus.
This progesterone Controlled Intravaginal Drug Release is a steroid hormone that allows out-of-season breeding in sheep.
Data
The data to support this approval were gathered in collaboration with the National Research Support Project-7, a USDA program intended to support the approval of new animal drugs for minor species of agricultural importance.
Clinical researchers funded by National Research Support Project-7 grants conducted the studies to support the effectiveness, target animal safety, human food safety and environmental safety of the progesterone Controlled Intravaginal Drug Release.
These data were made available in a Public Master File in March 2009. The pharmaceutical company was able to use these data in conjunction with its own manufacturing, labeling and other information to complete the new animal drug application.
Manufactured
EAZI-Breed Controlled Intravaginal Drug Release Sheep Insert is manufactured by Pharmacia and Upjohn, a division of Pfizer, Inc., New York, N.Y.
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