Merck & Co. announced that the U.S. Food and Drug Administration has granted a conditional approval for its new animal‑health product EXZOLT™ CATTLE‑CA1, a fluralaner‑based topical solution that prevents and treats New World Screwworm (Cochliomyia hominivorax) larvae in cattle.
The approval marks a milestone for Merck’s Animal Health division, which reported $5.9 billion in sales in 2024—a 4 % year‑over‑year increase (8 % excluding foreign‑exchange effects). The new product adds a novel ectoparasiticide to a portfolio that already includes the highly successful BRAVECTO® line, which generated $1.1 billion in companion‑animal sales last year.
The New World Screwworm has re‑emerged in the United States after its eradication in 1966, threatening cattle producers with potential losses in the hundreds of millions of dollars. Existing treatments are limited and often require multiple applications, creating a sizable market opportunity for a single‑application solution. EXZOLT CATTLE‑CA1 is the first product in its class to receive conditional approval for both prevention and treatment of screwworm and for control of cattle fever tick, positioning Merck as a leader in this niche market.
Under the FDA’s conditional‑approval pathway, Merck can market EXZOLT CATTLE‑CA1 immediately while continuing to collect data required for full approval. The company has indicated that the product will be available to veterinarians and producers in the first quarter of 2026, with a full‑approval filing expected within 12 months of launch.
Merck’s president of Animal Health, Rick DeLuca, emphasized the growing concern over screwworm and the risk of “devastating economic losses” if the parasite spreads unchecked. He noted that the conditional approval “reflects Merck’s commitment to delivering innovative solutions quickly to protect cattle and the industry’s economic future.”
The approval expands Merck’s footprint in a high‑growth livestock‑health segment, diversifying its revenue base beyond companion animals and positioning the company to capture a share of a market that has been underserved by existing treatments. With the product slated for launch in early 2026, Merck is poised to capitalize on a growing demand for effective, single‑application ectoparasiticides in the U.S. cattle industry.
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