Beef cowThe FDA granted conditional approval for Exzolt Cattle-CA1, a fluralaner topical treatment designed to prevent and treat New World screwworm (NWS) larvae in cattle as well as to control cattle fever tick. The treatment has been approved for beef cattle over two months old and replacement dairy heifers under 20 months. It is the first conditionally approved drug specifically targeting cattle fever tick.

Under the conditional approval pathway, the FDA verified the product’s safety and found a reasonable expectation of effectiveness. This gives the manufacturer, Intervet Inc., up to five years to submit additional data for full approval.

FDA officials said the decision reflects heightened efforts to provide veterinarians and producers with critical tools to protect livestock and the food supply from parasites such as NWS and cattle tick fever. Exzolt Cattle-CA1 received expedited review due to its priority zoonotic designation under the CARES Act.

The prescription-only pour-on treatment comes in multiple bottle sizes and carries a 98-day slaughter withdrawal period. It is not approved for lactating dairy cattle, dairy calves, veal calves or breeding bulls. Industry leaders, including Texas Agriculture Commissioner Sid Miller, praised the approval as a major step forward in safeguarding U.S. cattle health.

Read more about the FDA conditional New World Screwworm treatment approval here.