FDA Conditionally Approves Exzolt Cattle-CA1 for Parasitic Control in Cattle

The U.S. Food and Drug Administration (FDA) has granted conditional approval to Exzolt Cattle-CA1, a fluralaner-based topical solution, aimed at preventing and treating New World screwworm (NWS) larval infestations and controlling cattle fever tick in beef cattle and replacement dairy heifers. This approval, announced on December 4, 2025, marks the first conditional approval for a drug specifically targeting cattle fever tick.

According to Dr. Marty Makary, FDA Commissioner, while NWS has not yet been reported in the United States, the cattle fever tick is already present. The drug is designed for cattle aged two months and older, as well as dairy heifers under 20 months, and is not intended for lactating dairy cattle or veal calves. The withdrawal period before slaughter is set at 98 days to ensure food safety.

The approval is granted under the FDA's priority zoonotic animal drug (PZAD) designation, a measure enhanced by the CARES Act, allowing expedited review for drugs addressing significant unmet animal health needs. Timothy Schell, director of the FDA’s Center for Veterinary Medicine, emphasized the commitment to ensuring the safety and effectiveness of animal drugs.

Exzolt Cattle-CA1 is available in prescription bottles of 250 mL, 1L, and 5L, and its application involves administering the solution along the bovine's back. Intervet, Inc., the product's sponsor, has up to five years to provide further effectiveness data for full FDA approval.

The FDA cautions that antiparasitic drugs like Exzolt Cattle-CA1 should be used judiciously, in conjunction with comprehensive parasite management strategies, to prevent drug resistance.