FDA

Dec. 4 (UPI) — The Exzolt Cattle-CA1, aka Fluralaner, topical drug has received conditional approval from federal regulators to prevent and treat New World Screwworm and cattle fever tick infestations.

The Food and Drug Administration announced the approval on Thursday and said the topical drug will help to prevent NWS larval infestations and treat and control cattle fever in beef cattle that are at least two months old and young dairy cows that are younger than 20 months of age.

“This conditional approval gives cattle producers a new toll to combat two parasites threatening the well-being of cattle in the United States,” FDA Commissioner Marty Makary said.

“Although NWS has not been detected in the United States, the cattle fever tick is here,” Makary explained. “This is the first drug conditionally approved by the FDA specifically for the control and treatment of cattle fever tick.”

While the NWS has not been detected in cattle, a human infestation of the flesh-eating bacteria was reported in August after a person returned from a visit to El Salvador, according to the Health and Human Services Department.

The FDA has given preliminary approval of the drug’s use on cattle, but it requires maker Intervet Inc. of Rahway, N.J., to generate and provide additional data within five years that demonstrate its effectiveness to obtain full approval from the federal agency.

“The FDA is leveraging every resource and authority at its disposal to ensure [beef and milk] producers and their veterinarians have the critical products they need to protect their livestock and safeguard our food supply against NWS and the cattle fever tick,” said Timothy Schell, director of the FDA’s Center for Veterinary Medicine.

The FDA said it granted conditional approval for Exzolt Cattle-CA1 because it is a priority zoonotic animal drug intended to prevent and treat serious or life-threatening diseases in cattle.

The topical drug is a single-use product that is available only by prescription and is sold in 250 ml, 1-liter and 5-liter bottles.

It is applied directly to the hair and skin of cattle in a narrow strip running along the top of its back from between the shoulder blades to the base of the tail.

The FDA has approved the emergency use of other NWS drugs amid rising infestations in Central America.

Officials in Mexico have taken a proactive approach to countering the screwworm’s re-emergence there after it had been deemed eradicated more than 20 years ago.

Its discovery in cattle in southern Mexico prompted U.S.officials to suspend cattle exports from Mexico, which is where more than a million Mexican cattle are sent annually.