Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

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

The drug is for use in food-producing animals.

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.

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging