FDA Conditionally Approves New Topical Treatment for Screwworm and Cattle Fever Tick
The Food and Drug Administration (FDA) has announced the conditional approval of a new topical medicine designed to help protect U.S. cattle from two serious parasitic threats. Exzolt Cattle-CA1 has been approved for the prevention and treatment of larval infestations of New World Screwworm (NWS) and is also effective for the treatment and control of cattle fever tick.
Exzolt Cattle-CA1 is approved for use in beef cattle two months of age and older, as well as replacement dairy heifers under 20 months of age. The approval provides cattle producers and veterinarians with an additional tool to safeguard animal health and support the nation’s food supply.
The FDA’s conditional approval indicates that the agency has determined the product is “safe and has a reasonable expectation of effectiveness for its intended use.” Conditional approvals allow animal drug sponsors to make products available while collecting additional data required for full approval, particularly in cases involving emerging or high-risk animal health concerns.
FDA Commissioner Marty Makary highlighted the significance of the approval, saying, “This conditional approval gives cattle producers a new tool to combat two parasites threatening the well-being of cattle in the U.S.Although NWS has not been detected in the U.S., cattle fever tick is here. This is the first drug conditionally approved by the FDA specifically for the control and treatment of cattle fever tick.”
While New World Screwworm is not currently present in the United States, the parasite poses a serious risk due to its ability to cause severe tissue damage and economic losses if reintroduced. Cattle fever tick, meanwhile, remains an ongoing concern in parts of the country, particularly due to its role in transmitting bovine babesiosis.
Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine, emphasized the agency’s broader commitment to livestock protection, stating, “The FDA is leveraging every resource and authority at its disposal to ensure producers and veterinarians have the critical products they need to protect their livestock and safeguard our food supply against NWS and cattle fever tick. We remain steadfast in our commitment to ensuring that animal drugs are safe and effective and that food from treated animals is safe to eat.”
The conditional approval of Exzolt Cattle-CA1 marks a notable step forward in parasite control options for the cattle industry, strengthening preparedness efforts and reinforcing animal health protections nationwide.
Audio Reporting by Dale Sandlin for Southeast AgNet.