Austin, Texas, December 5, 2025
The FDA has conditionally approved Exzolt Cattle-CA1, a topical solution aimed at preventing and treating New World screwworm infestations in cattle. This innovative product, developed by Intervet Inc., promises to bolster livestock health and signals progress for Texas beef producers. Exzolt Cattle-CA1, containing the active ingredient fluralaner, will be prescribed in various sizes starting in 2026. As the threat of New World screwworm edges closer to the U.S., this development is significant for both cattle health and the agricultural economy.
FDA Grants Conditional Approval for New Livestock Treatment
A New Hope for Livestock Health in America
AUSTIN, Texas — The U.S. Food and Drug Administration has conditionally approved a new topical solution, Exzolt Cattle-CA1, targeted at preventing and treating New World screwworm infestations in cattle. This approval signals a significant step forward in protecting livestock health, an essential aspect of the agricultural economy. As Texas remains a leader in beef production, local producers stand poised to benefit from this innovative solution that empowers them to combat a threatening parasite.
Exzolt Cattle-CA1 is an example of how focused research and development can yield impactful solutions for farmers and ranchers. The introduction of this product reflects a commitment to robust livestock management practices and underscores the positive role of innovation in our local agricultural sector. In Texas, where cattle ranching is a cornerstone of the economy, the implications of this advancement could be profound.
Details of the Approval
Exzolt Cattle-CA1, developed by Intervet Inc., is a pour-on solution containing the active ingredient fluralaner. This product has been approved for use in beef cattle aged two months and older, and replacement dairy heifers under 20 months. The FDA’s conditional approval is based on safety assessments and the expectation of effectiveness. It will be available by prescription in various sizes starting in the first quarter of 2026, with a necessary meat withdrawal period of 98 days post-treatment to ensure safety for human consumption. Notably, the product is not approved for use in lactating dairy cattle, dairy calves, veal calves, or bulls intended for breeding.
Significance of the Approval
New World screwworm, a parasitic fly that lays eggs in open wounds, poses a significant threat to livestock health by leading to potentially devastating infestations. Fortunately, while NWS has not yet been detected in the U.S., the introduction of Exzolt Cattle-CA1 offers cattle producers a proactive tool to ensure the continued health of their herds. The implications for livestock and food security are critical, as well as for the economic well-being of the national cattle industry.
Background on New World Screwworm
Historically, New World screwworm infestations have led to severe economic losses within the cattle industry. Though the parasite has been eradicated from North and Central America for decades, recent patterns indicate its northern movement brings it closer to the U.S. southern border. Effectively, the threat to livestock underscores not just agricultural resilience but also national security concerns regarding food supply and animal health.
Additional Developments
In September 2025, the FDA also conditionally approved Dectomax-CA1, an injectable solution designed for the prevention and treatment of NWS infestations in cattle. This innovative product represents the first of its kind, highlighting the ongoing advancements in livestock treatments and the expanding repertoire of tools available to cattle producers.
Conclusion
The conditional approval of Exzolt Cattle-CA1 is a welcome development in the effort to protect U.S. cattle against the threats posed by New World screwworm. This new treatment not only equips producers with essential tools for livestock health management but also reflects a community-focused approach to enhancing agricultural outcomes. As local entrepreneurs, ranchers, and farmers continue to innovate and adapt, backing such advancements ensures the prosperity of Texas’s agricultural sector.
Frequently Asked Questions (FAQ)
What is Exzolt Cattle-CA1?
Exzolt Cattle-CA1 is a topical solution containing fluralaner, approved by the FDA for the prevention and treatment of New World screwworm infestations in cattle. It is available by prescription in 250 mL, 1 L, and 5 L bottles starting in the first quarter of 2026.
Who can use Exzolt Cattle-CA1?
The product is approved for use in beef cattle aged two months and older, as well as replacement dairy heifers under 20 months. It is not approved for use in lactating dairy cattle, dairy calves, veal calves, or bulls intended for breeding.
What is New World screwworm?
New World screwworm is a parasitic fly that lays eggs in open wounds and mucous membranes, leading to infestations that can be devastating to livestock. While NWS has not been detected in the U.S., the approval of Exzolt Cattle-CA1 provides cattle producers with a new tool to prevent potential infestations.
What other treatments are available for New World screwworm?
In September 2025, the FDA conditionally approved Dectomax-CA1, an injectable solution for the prevention and treatment of NWS infestations in cattle. This product, developed by Zoetis, is the first and only parasite control product to receive such approval for NWS in cattle.
Why is the approval of Exzolt Cattle-CA1 significant?
The approval of Exzolt Cattle-CA1 provides cattle producers with a new tool to combat two parasites threatening the well-being of cattle in the U.S.
Key Features of Exzolt Cattle-CA1
| Feature | Details |
|---|---|
| Active Ingredient | Fluralaner |
| Approved Use | Prevention and treatment of New World screwworm infestations in cattle |
| Target Animals | Beef cattle aged two months and older, replacement dairy heifers under 20 months |
| Not Approved For | Lactating dairy cattle, dairy calves, veal calves, bulls intended for breeding |
| Withdrawal Period | 98 days post-treatment |
| Availability | By prescription in 250 mL, 1 L, and 5 L bottles starting in the first quarter of 2026 |
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Author: STAFF HERE AUSTIN WRITER
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