What's Happening?
Merck Animal Health has received conditional approval from the FDA for its new product, Exolt Cattle-CA1, designed to combat New World Screwworm and cattle fever tick. This is the first novel ectoparasiticide
introduced for beef cattle in several decades. The product, which includes the active ingredient fluralaner, is approved for use in beef cattle two months of age and older and replacement dairy heifers under 20 months. However, it is not approved for bulls intended for breeding, dairy calves, or veal calves. The approval is pending a full demonstration of effectiveness, and off-label use is federally prohibited. Merck plans to make the product available by prescription in early 2026.
Why It's Important?
The conditional approval of Exolt Cattle-CA1 is significant for U.S. agriculture, as New World Screwworm poses a serious threat to cattle producers, potentially leading to economic losses in the hundreds of millions of dollars. The introduction of this novel treatment reflects Merck's commitment to providing innovative solutions to address resistance concerns in parasite management. By accelerating the availability of this product, the FDA is supporting efforts to safeguard the economic future of the cattle industry and the nation's beef supply.
What's Next?
Merck Animal Health plans to make Exolt Cattle-CA1 available by prescription in early 2026. The company will continue to work closely with the FDA to demonstrate the product's effectiveness fully. As the product becomes available, cattle producers and veterinarians will have access to a new tool to protect cattle from serious parasites, potentially reducing economic losses and ensuring the stability of the beef supply.
