FDA authorizes CLiK Extra to prevent screwworm in sheep, cattle, goats and swine

Source: www.fda.gov
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The US Food and Drug Administration has issued an Emergency Use Authorization for Elanco’s CLiK Extra wound spray to help prevent New World screwworm infestations in several livestock species. The authorization also covers camelids and specified captive or captured wildlife, including deer, elk, bison and bighorn sheep.
FDA authorizes CLiK Extra to prevent screwworm in sheep, cattle, goats and swine

On August 7th, the FDA authorized CLiK Extra, a topical suspension containing dicyclanil, for use on or around wounds in sheep, cattle, goats, swine and camelids such as camels, llamas and alpacas. The emergency authorization also includes captive and captured cervids, American bison, bighorn sheep and Sonoran pronghorn.

The product is intended to prevent New World screwworm myiasis linked to wounds, birth, or surgical and husbandry procedures. The listed procedures include dehorning, ear tagging, castration, tail docking and shearing. The spray is applied when a wound appears or is created, and it is available over the counter for topical use.

CLiK Extra does not kill screwworm larvae directly. It acts as an insect-growth regulator, interrupting larval development and stopping the insects’ life cycle before they damage the host animal’s tissue. The authorization does not cover wounds that are already infested. If an infestation occurs after application, the FDA advises contacting a veterinarian about treatment.

The FDA said its review of the available scientific evidence supported a reasonable belief that the spray could be effective when used under the authorization. The agency also determined that the product’s known and potential benefits outweighed its known and potential risks. Acting FDA Commissioner Kyle Diamantas described the authorization as an additional tool for farmers, ranchers, veterinarians and wildlife managers.

Timothy Schell, director of the FDA’s Center for Veterinary Medicine, said the agency included specified wildlife because New World screwworm affects animals beyond farms. He said protecting captive and captured wildlife could help prevent those animals from contributing to the pest’s spread in the United States.

CLiK Extra is not FDA-approved or conditionally approved for any indication. The emergency authorization will remain effective until the FDA revokes it or the US health secretary ends the declaration that a potential public-health emergency from New World screwworm justifies emergency authorization of animal drugs. Elanco US, based in Indianapolis, sponsors the product.


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