- EXZOLT CATTLE-CA1 uses fluralaner, an isoxazoline, for parasite control.
- FDA granted conditional approval based on safety and expected effectiveness.
- Available by prescription in 1 L or 5 L from Q1 2026.
- 98-day meat withdrawal period required post-treatment.
Product Overview
EXZOLT CATTLE-CA1, a fluralaner topical solution, is the first in its class conditionally approved by the FDA for both prevention and treatment of New World screwworm and control of cattle fever tick. It belongs to the isoxazoline class of parasiticides and is designed for use in beef cattle aged two months and older, as well as replacement dairy heifers under 20 months.
Regulatory Approval
The FDA granted conditional approval based on safety and a reasonable expectation of effectiveness, following global studies conducted by Merck Animal Health. This approval allows for accelerated availability of the product to address significant agricultural concerns.
Usage and Restrictions
EXZOLT CATTLE-CA1 is a pour-on solution that acts systemically against infestations. It is not approved for use in bulls intended for breeding, dairy calves, or veal calves. A 98-day meat withdrawal period is required after treatment to ensure safety for human consumption.
Availability
The product will be available by prescription in 1 L or 5 L presentations starting in the first quarter of 2026. Its use is restricted to labeled indications, with off-label use prohibited by federal law for conditionally approved products.
