FDA Approves First Drug For Prevention and Treatment of New World Screwworm

FDA Approves First Drug for New World Screwworm in Cattle: Dectomax-CA1

In a major step forward for livestock health and protection, the U.S. Food and Drug Administration (FDA) has conditionally approved the first drug in the U.S. for the prevention and treatment of New World Screwworm (NWS).

“The U.S. Food and Drug Administration has conditionally approved the first drug for the prevention and treatment of New World Screwworm. Dectomax-CA1, from Zoetis, has been conditionally approved for use only in cattle, as an injectable solution for the prevention and treatment of New World Screwworm larval infestation. The product can also be used for the prevention of reinfestation of New World Screwworm for 21 days.”

This conditional approval marks a critical advancement in protecting American livestock, particularly as USDA and producers remain vigilant against NWS outbreaks near the southern U.S. border.

“FDA Commissioner Marty Makary, M.D., M.P.H. said, ‘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.'”

The FDA also clarified the scientific basis behind the expedited approval process.

“According to the FDA, ‘Dectomax is already fully approved under a New Animal Drug Application for treatment and control of certain nematode and arthropod parasites in cattle and swine. Dectomax and Dectomax-CA1 contain the same active ingredient (doramectin injection) at the same dose. Because the original approval of Dectomax included adequate target animal safety studies, manufacturing information, and human food safety information, the FDA did not require new information to support those aspects for the conditional approval of Dectomax-CA1.'”

The withdrawal period for Dectomax-CA1 is 35 days, ensuring safe use in food-producing cattle.

“Timothy Schell, Ph.D., acting director of the FDA’s Center for Veterinary Medicine said, ‘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. 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.'”

Livestock producers can now access this new tool as part of broader efforts to safeguard cattle from parasitic threats like the New World Screwworm.

Audio Reporting by Dale Sandlin for Southeast AgNet.