Approval marks second animal drug approval under collaborative initiative with Canada
June 3, 2014
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced today the approval of BRAVECTO (fluralaner) Chewable Tablets for Dogs, the first oral flea and tick medication that lasts up to 12 weeks. The drug treats and prevents fleas for 12 weeks; treats and controls three types of ticks—the brown dog tick, American dog tick and deer tick—for 12 weeks; and treats and controls the lone star tick for 8 weeks.
The approval of BRAVECTO is in cooperation with Health Canada’s Veterinary Drugs Directorate (VDD), under the Regulatory Cooperation Council (RCC) joint initiative which aims to better align the approval process for these products. While maintaining safety standards, the RCC is intended to speed access to products, eliminate duplication, and reduce regulatory obstacles that can slow trade and investment opportunities as well as add costs to manufacturers and consumers. Under this initiative, FDA and VDD 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.
The product is being marketed by Intervet Inc. and requires a valid prescription from a veterinarian for its use.