FDA approves new topical drug for treating screwworm and fever tick in cattle

Dec. 4 (UPI) -- The FDA has given conditional approval to Exzolt Cattle-CA1, also known as Fluralaner, a topical medication designed to prevent and treat infestations of New World Screwworm (NWS) and cattle fever ticks. The drug can be used on beef cattle aged two months and older, as well as dairy cows under 20 months of age.

"This approval provides cattle farmers with a new tool to protect livestock from two significant parasites affecting U.S. herds," said FDA Commissioner Marty Makary. He noted that while NWS has not yet been detected in the United States, cattle fever ticks are present, making this the first FDA-approved drug specifically for their control and treatment.

Although there are no reports of NWS in U.S. cattle, a human case was recorded in August after an individual returned from El Salvador, according to the Department of Health and Human Services.

The FDA's conditional approval allows the medication to be used while requiring Intervet Inc., the manufacturer based in Rahway, N.J., to submit additional data within five years to demonstrate the drugs full effectiveness for complete FDA approval.

"The FDA is utilizing all available resources to ensure livestock producers and veterinarians have access to essential products to protect cattle and maintain the food supply against NWS and cattle fever ticks," said Timothy Schell, director of the FDA's Center for Veterinary Medicine.

Exzolt Cattle-CA1 has been designated as a priority zoonotic animal drug due to its role in preventing and treating serious diseases in cattle. The single-use topical solution is prescription-only and is available in 250 ml, 1-liter, and 5-liter bottles. It is applied in a narrow strip along the back, from the shoulder blades to the tail base.

Officials have previously approved emergency use of other medications against NWS amid outbreaks in Central America. Mexico has also implemented proactive measures following the reappearance of screwworm in southern cattle herds, leading U.S. authorities to temporarily halt cattle imports from the region, which typically supplies over a million head of cattle annually.

FDA's Conditional Approval of Exzolt Cattle-CA1: Key Insights and Implications

The FDA's recent conditional approval of Exzolt Cattle-CA1, a topical treatment for New World Screwworm (NWS) and cattle fever ticks, marks a significant step in livestock health management. Though the approval is conditioned upon additional data submission, it provides U.S. cattle farmers with an essential new tool. As stated by FDA Commissioner Marty Makary, while NWS has not been detected in the U.S., the prevalence of cattle fever ticks warrants the approval of this drug, which is the first FDA-sanctioned treatment for this issue.

Despite no confirmed cases of NWS in U.S. herds, the drug's potential extends beyond just tick control. This approval is timely, as NWS has been reported in humans who traveled from regions like El Salvador, illustrating the zoonotic risks associated with these pests. Furthermore, the FDA’s recognition of Exzolt Cattle-CA1 as a priority zoonotic animal drug emphasizes its broader importance to public health and agriculture.

The conditional approval does not allow for complacency, however. The manufacturer, Intervet Inc., is required to provide further data within five years to gain full approval. This ensures that the drug's safety and efficacy are thoroughly assessed before it becomes a permanent solution. In the meantime, the FDA's swift action reflects its commitment to safeguarding both livestock and the U.S. food supply.

Sources:

• FDA approves topical cattle drug for screwworm, fever tick

Author: Logan Reeves
Logan Reeves is a sports analyst and journalist. He writes match reviews, conducts athlete interviews, and produces data-driven predictions.