Merck Unit Gets FDA Conditional Approval For EXZOLT CATTLE-CA1 To Treat Key Cattle Parasites

(RTTNews) - Merck Animal Health, a division of Merck & Co., Inc.(MRK), announced that the U.S. Food and Drug Administration has granted conditional approval for EXZOLT CATTLE-CA1 (fluralaner topical solution).

This inovative product belongs to the newest class of parasiticides known as isoxazolines. Formulated as a pour-on solution, EXZOLT CATTLE-CA1 is effective in preventing and treating infestations caused by New World screwworm (Cochliomyia hominivorax) larvae, which lead to myiasis in cattle.

In addition, the product has received conditional approval for the treatment and control of cattle fever tick (Rhipicephalus microplus), further expanding its potential role in safeguarding livestock health and productivity.

EXZOLT CATTLE-CA1 is a pour-on that delivers the active ingredient fluralaner to act systemically against infestations. It is approved for use in beef cattle two months of age and older, and in replacement dairy heifers under 20 months. It is not approved for use in bulls intended for breeding (one year of age and older), dairy calves, and veal calves. There is a 98-day meat withdrawal period.

EXZOLT CATTLE-CA1 will be available by prescription in 1 L or 5 L presentations in the first quarter of 2026. Use of EXZOLT CATTLE-CA1 is restricted to the labeled indications; off-label or extra-label use is prohibited by federal law for conditionally approved products.

Merck Animal Health recently received market authorization in Mexico for this product for the prevention and treatment of New World screwworm to help control the spread of the parasite and protect cattle.

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