Government of Canada announces simultaneous approval with the United States of veterinary drug Imrestor

Provides dairy farmers with an innovative drug to prevent common infection in cattle

OTTAWA, March 24, 2016 /CNW/ - Health Canada and the United States Food and Drug Administration's Center for Veterinary Medicine today announced a simultaneous approval of the veterinary drug Imrestor. Access to this drug will provide Canadian dairy farmers with an innovative product to reduce the incidence of clinical mastitis, a significant infectious disease that affects approximately 15% of dairy cattle.

At the time of calving, dairy cows often have a lowered immune system, which can lead to infections. Imrestor is an innovative drug that restores immune response and reduces the incidence of clinical mastitis—reducing reliance on other drugs, including antimicrobials, to treat mastitis infections.

This is the fourth drug to be approved under the Regulatory Cooperation Council (RCC), but it is the first drug to be approved for use in food-producing animals.

Quick Facts:

• Mastitis in dairy cattle is common, underscoring the importance of timely approval of this innovative drug.
• Clinical mastitis is the inflammation of the mammary gland and udder tissue. It is a serious disease in dairy cattle and can cause a reduced milk yield, damage to a cow's udder tissue as well as significant pain.
• The Canada–United States Regulatory Cooperation Council (RCC) is an agreement between Canada and the United States with a mandate of working together to promote economic growth, job creation, and benefits to consumers and businesses through increased regulatory transparency and coordination between the two countries.

Quote:

"This drug's approval will provide Canadian dairy farmers with access to an innovative product to treat a common but serious condition, and likely lead to fewer animals needing treatment from antimicrobial drugs. Thanks to our government's collaboration with our American counterparts, the approval was able to be expedited and will help to improve the health and well-being of Canadian cattle."
The Honourable Jane Philpott
Minister of Health

Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media

SOURCE Health Canada

For further information: Andrew MacKendrick, Office of Jane Philpott, Minister of Health, 613-957-0200; Media Relations: Health Canada, 613-957-2983; Public Inquiries: 613-957-2991, 1-866 225-0709