Merck division gets USFDA conditional approval for Exzolt Cattle-CA1 against cattle fever tick
Rahway: Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA, has announced that the U.S. Food and Drug Administration (FDA) has granted a conditional approval for EXZOLT CATTLE-CA1 (fluralaner topical solution).
This product is in the newest class of parasiticides known as isoxazolines. The pour-on solution is effective for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis). It is also conditionally approved for the treatment and control of cattle fever tick (Rhipicephalus microplus).
“The threat of New World screwworm represents a growing concern to U.S. agriculture, potentially causing devastating economic losses for cattle producers that could reach hundreds of millions of dollars,” said Rick DeLuca, president, Merck Animal Health. “EXZOLT CATTLE-CA1 is the first novel ectoparasiticide introduced for beef cattle in several decades, and its conditional approval reflects our commitment to bringing new, innovative solutions to market that address resistance concerns. We worked closely with the FDA to accelerate availability so that veterinarians and cattle producers will have access to a powerful new tool to protect cattle from these serious parasites, helping to safeguard the industry’s economic future and the nation’s beef supply.”
EXZOLT CATTLE-CA1 was granted conditional approval based on demonstration of safety and a reasonable expectation of effectiveness when administered according to label directions based on global studies conducted by Merck Animal Health in recent years.
“Merck Animal Health has a proud legacy of innovation, providing science-based solutions and supporting producers in adopting sustainable parasite management programs including resistance control,” said Holger Lehmann, D.V.M., Ph.D., vice president, pharmaceutical research & development, Merck Animal Health. “We are pleased that the FDA previously established an accelerated regulatory pathway for novel treatments that address life-threatening diseases through expanded conditional approval and priority zoonotic animal drug designation. Without this regulatory route, the registration of EXZOLT CATTLE-CA1 would not have been possible in such a short time.”
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 is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-617.
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.
