The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra (dicyclanil topical suspension) wound spray to help prevent New World screwworm infestations in a broad range of domestic, livestock and wildlife species.

According to a news release from agency, the authorization covers sheep, cattle, goats, swine and camelids, including camels, llamas and alpacas. It also applies to certain captive and captured wildlife species, including cervids such as deer and elk, American bison, bighorn sheep and Sonoran pronghorn.

“Under President Trump’s leadership, we are giving American farmers, ranchers, veterinarians and wildlife managers the tools they need to fight back,” said Acting FDA Commissioner Kyle Diamantas, J.D. in the release “Today's emergency use authorization provides a new tool for preventing the spread of New World screwworm infestations, and we will continue to work to combat this threatening pest.”

The FDA said its decision was based on the totality of the available scientific evidence. The agency concluded it is reasonable to believe CLiK Extra wound spray may be effective in preventing New World screwworm, or NWS, myiasis when used as authorized. The FDA also determined the product's known and potential benefits outweigh its known and potential risks.

The authorization is limited to preventing NWS myiasis associated with wounds, birth and surgical or husbandry procedures. Those procedures include dehorning, ear tagging, castration, tail docking and shearing.

CLiK Extra wound spray is applied when a wound appears or is created. The authorization does not cover treatment of an existing infestation. If a wound is already infested or an infestation develops after the product is administered, the FDA advises contacting a veterinarian to discuss treatment options.

The product is available over the counter for topical use on or around wounds. Rather than killing New World screwworm larvae, CLiK Extra acts as an insect growth regulator that disrupts larval development and halts the insects' lifecycle before they can cause tissue damage in the host animal.

The authorization also extends to wildlife species because of concerns that infected animals could contribute to the spread of New World screwworm in the United States.

“The FDA recognizes that the impact of New World screwworm extends beyond the farm gate,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “Authorizing this product for captive and captured wildlife species, including bighorn sheep, Sonoran pronghorn, American bison, and cervids like deer and elk, is about protecting these animals and helping ensure they do not contribute to the spread of NWS in the United States.”

Despite the emergency authorization, CLiK Extra wound spray is not approved or conditionally approved by the FDA for any indication.

The FDA said detailed product information, including important food safety information, is available in the Fact Sheet: Emergency Use Authorization of CLiK Extra (dicyclanil topical suspension) Wound Spray for New World Screwworm (NWS).

The EUA will remain effective until it is revoked or until the HHS secretary terminates the declaration that the potential public health emergency presented by New World screwworm justifies the emergency use authorization of animal drugs for NWS.

CLiK Extra wound spray is sponsored by Elanco US Inc., which is based in Indianapolis, Indiana.