March 29, 2016
The U.S. Food and Drug Administration, in cooperation with Health Canada, announced today the simultaneous approval of Imrestor (pegbovigrastim injection), a new animal drug intended to reduce the incidence of clinical mastitis of dairy cows and replacement dairy heifers. This is the first simultaneously reviewed and approved animal drug for use in food-producing animals. Imrestor’s approval marks the fourth animal drug approved under collaborative initiative with Canada. The other drugs approved under this initiative are: Simparica (Sarolaner Chewable Tablet), Comfortis (spinosad), and Bravecto (fluralaner).
The simultaneous approval of Imrestor was done under the Regulatory Cooperation Council (RCC) Initiative which aims to better align the approval process for these products. The RCC is an agreement between the United States and Canada with a mandate of working together to promote economic growth, job creation, and benefits to consumers and business through increased regulatory transparency and coordination between the two countries. Under this initiative, FDA and Health Canada allow simultaneous submissions and collaborative reviews where possible, while maintaining each country’s right to decide whether or not products will be approved for its market.
Elanco Animal Health, a Division of Eli Lilly & Co. sponsored the application for Imrestor.