Health Canada and U.S. Food and Drug Administration complete another simultaneous review of veterinary drug product
Flea and tick control product gets green light under Regulatory Co-operation Council project
June 3, 2014
Health Canada and the U.S. Food and Drug Administration's Center for Veterinary Medicine today announced another simultaneous review and approval of a veterinary drug application under an initiative to better align the approval process for these products.
Bravecto (fluralaner chewable tablets), the product that received approval, is used to kill fleas and is indicated for the prevention and treatment of flea infestations in dogs. Bravecto is also approved to treat and control or aid in the control of ticks. The product is marketed by Merck.
Under an initiative of the Canada-United States Regulatory Cooperation Council (RCC), Health Canada and the FDA worked collaboratively from the same fundamental effectiveness, target animal safety and quality data sets to approve Bravecto.
Building on an established and strong relationship, Health Canada and the FDA were able to perform a collaborative review with more consistent labeling of the product as it is marketed in both the Canada and the U.S.
Health Canada and the FDA plan to build a process to 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.
More information on the overall RCC initiative can be found on Canada's Economic Action Plan website.
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