FDA授权Elanco的CLiK Extra用于多物种新世界螺旋虫预防

FDA News Release
FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
- For Immediate Release:
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds for the prevention of New World screwworm (NWS) infestations (myiasis) in sheep, cattle, goats, swine, camelids (e.g., camels, llamas, alpacas), and the following captive and captured wildlife species: cervids (e.g., deer, 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. “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.”
Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that CLiK Extra wound spray may be effective in the prevention of NWS myiasis when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks.
“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.”
This EUA authorizes CLiK Extra wound spray only for prevention of NWS myiasis associated with wounds, birth, and after surgical or husbandry procedures (e.g., dehorning, ear tagging, castration, tail docking, shearing). It is applied at the time of wound appearance or creation. If a wound is already infested, or if an infestation develops after administering the product, contact a veterinarian to discuss treatment options.
CLiK Extra wound spray is available over the counter for topical use on or around wounds. Rather than killing NWS larvae, it acts as an insect growth regulator that disrupts the development of larvae and halts their lifecycle before they can cause tissue damage in the host animal.
CLiK Extra wound spray is not approved or conditionally approved by the FDA for any indication.
Detailed product information about CLiK Extra wound spray, including important food safety information, can be found in the Fact Sheet: Emergency Use Authorization of CLiK Extra (dicyclanil topical suspension) Wound Spray for New World Screwworm (NWS).
This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.
CLiK Extra wound spray is sponsored by Elanco US Inc. based in Indianapolis, Indiana.
Related Information
- Freedom of Information Summary: CLiK Extra Wound Spray (EUA 006723)
- Letter of Authorization: CLiK Extra Wound Spray (EUA 006723)
- Fact Sheet: Emergency Use Authorization of CLiK Extra (dicyclanil topical suspension) Wound Spray for New World Screwworm (NWS)
- Animal Drugs for New World Screwworm
- Emergency Use Authorization of Animal Drugs for NWS
- Screwworm.gov – Unified Government Response to Protect the United States
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
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