The U.S. Food and Drug Administration on Dec. 4 granted conditional approval for Exzolt Cattle-CA1, a topical solution to prevent and treat New World screwworm larval infestations and control cattle fever tick in beef cattle and replacement dairy heifers.

The drug is approved for use in beef cattle 2 months and older and dairy heifers under 20 months of age per a news release.

“This conditional approval gives cattle producers a new tool to combat two parasites threatening the well-being of cattle in the U.S.,” FDA Commissioner Marty Makary, M.D., M.P.H., said in the release. “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.”

Exzolt Cattle-CA1, developed by Intervet, Inc. of Rahway, New Jersey, has been found safe with a reasonable expectation of effectiveness for its intended uses. Under the conditional approval, the company has up to five years to provide additional data to support full FDA approval.

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

Exzolt Cattle-CA1 qualified for conditional approval because it addresses serious or life-threatening diseases in cattle, meets unmet animal health needs, and its effectiveness requires complex studies. The drug received expedited review through a priority zoonotic animal drug designation, a mechanism authorized under the Coronavirus Aid, Relief, and Economic Security Act.

To protect human health, the slaughter withdrawal period for treated cattle is 98 days. The product is not approved for use in lactating dairy cattle, dairy calves, veal calves, or bulls 1 year and older intended for breeding.

The prescription-only solution comes in 250 mL, 1L, and 5L bottles and is applied as a narrow strip along the top of a cow’s back from the withers to the tailhead. Experts emphasize that antiparasitic drugs should be used only when medically necessary, following label directions, and as part of a broader parasite management strategy.

For more information, visit www.fda.gov.