Regulatory First: FDA, Health Canada Simultaneous Review, Approve Veterinary Drug

The FDA and Health Canada simulatiously approved a new animal drug intended to reduce the incidence of clinical mastitis of dairy cows and replacement dairy heifers, according to the FDA.

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 simultaneous approval of Imrestor was done under the Regulatory Cooperation Council 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.