FDA conditionally approves Zoetis’ Dectomax-CA1 in cattle

The U.S. Food and Drug Administration conditionally approved Dectomax-CA1 injectable solution for the prevention and treatment of New World screwworm larval infestations, and prevention of NWS reinfestation for 21 days. Dectomax-CA1 is conditionally approved for use only in cattle. “We understand the urgency with which America’s farmers and ranchers are asking for tools to fight New World screwworm,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Today’s conditional approval – the first in the U.S. for NWS – shows our dedication to rapidly advancing important animal medicines when they are needed most. We continue to work tirelessly to complete review of other NWS products to protect multiple animal species in the U.S.” Dectomax-CA1 is eligible for conditional approval because it is intended to prevent and treat a serious or life-threatening disease in cattle, it addresses an unmet animal health need, and demonstrating effectiveness of the drug would require complex or particularly difficult studies. Dectomax-CA1 is sponsored by Zoetis (ZTS), based in Kalamazoo, Michigan. “Under this conditional approval, the FDA has determined the drug is safe and has a reasonable expectation of effectiveness. We are making this treatment available to cattle producers immediately while the sponsor collects the data needed for a full approval,” said Timothy Schell, Ph.D., acting director of the FDA’s Center for Veterinary Medicine. “The FDA will continue to expedite review of animal drugs to help the U.S. fight this devastating threat to our nation’s livestock and the livelihoods of the farmers and ranchers who care for them.”