The U.S. Food and Drug Administration (FDA) granted conditional approval for a drug meant to prevent New World screwworm infestations.
The agency authorized limited use of Dectomax-CA1, an injectable drug produced by Zoetis that aims to treat New World screwworm larval infestations and prevent reinfestation for 21 days.
It has the same active ingredient as Dectomax, which is already approved to treat certain parasites in cattle and swine.
“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.”
FDA said Dectomax-CA1 qualifies for conditional approval because it targets and treats a serious or life-threatening disease in cattle. It also addresses an unmet animal health need and demonstrating effectiveness of the drug would require complex or particularly difficult studies.
According to Zoetis, the conditional approval applies to beef cattle, female dairy cattle less than 20 months of age, pregnant beef cows, newborn calves and bulls.
Ranchers are encouraged to work closely with their herd veterinarian to implement strategic prevention and control measures.
“Ranchers are on edge knowing the New World screwworm is this close to the border,” said Tracy Tomascik, Texas Farm Bureau associate director of Commodity and Regulatory Activities. “Conditional approval of this treatment offers some reassurance, but we must continue pushing for long-term solutions to keep our herds safe.”
Last month, Mexico confirmed a case of New World screwworm 70 miles from the U.S.-Mexico border.
FDA will continue to expedite review of animal drugs to help ranchers combat the devasting threat of the New World screwworm.
Click here for more information on Dectomax-CA1.
