Announcement • 8h
Elanco Animal Health Incorporated Receives FDA Emergency Use Authorization for CLiK™ Extra Wound Spray for Prevention of New World Screwworm in Livestock and Wildlife
Elanco Animal Health Incorporated had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds to prevent infestations of New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in sheep, cattle, goats, swine and camelids, as well as captive and captured cervids, American bison, bighorn sheep and Sonoran pronghorn. Livestock producers and veterinarians can apply Elanco's CLiK Extra spray on or around wounds, including those associated with birth and following surgical procedures, on animals to help prevent infestations of New World screwworm larvae before they occur. However, if a wound is already infested or an infestation develops after administration, alternative treatment will be necessary since CLiK Extra has not been shown to treat active New World screwworm infestations. Elanco's Negasunt Powder and Tanidil received emergency authorizations for prevention and treatment of New World screwworm earlier this year. These products will be available only through the U.S. Animal Plant Health and Inspection Service (APHIS) and its National Veterinary Stockpile as distributed in coordination with state animal health officials and federally recognized tribal agencies. Elanco also offers producers Catron IV, one of the few EPA registered products labeled for treatment against screwworm in a variety of livestock species. This screwworm and ear tick spray can help producers kill and control screwworm flies and maggots on beef and dairy cattle, sheep, goats, hogs and horses. The reentry of New World screwworm into the U.S., which was confirmed by the United States Department of Agriculture in June, poses a critical risk to farmers and ranchers, pet owners and the veterinary community. Unlike other pests, screwworm larvae aggressively consume the living flesh of their hosts, making them a danger to any warm-blooded animal, ranging from livestock and companion animals to wildlife and humans. CLiK Extra will be available for purchase by animal health professionals, livestock producers and those managing captive and captured wildlife through standard product channels. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product CLiK Extra for application on or around wounds for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. CLiK Extra is not approved for this use. Sheep, cattle, goats, swine, cervids, American bison, and bighorn sheep must not be slaughtered or harvested for human consumption within 86 days of treatment. For captured cervids, captured American bison, and captured bighorn sheep, use only when there is a reasonable certainty that the treated animal will not be slaughtered or harvested for human consumption within 86 days of treatment. Treated Sonoran pronghorn and camelids may not be used for human consumption. A milk discard time has not been established for this product. Do not use in animals producing milk for human consumption. A withdrawal period has not been established for this product in pre-ruminating calves. Treated calves and calves born to treated cows must not be processed for veal. CLiK Extra is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of CLiK Extra under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner. Not for use in humans. Keep out of reach of children. Use disposable gloves and protective clothing when handling this product, and wash hands after use. In case of accidental ingestion, do not induce vomiting; seek medical advice immediately. For external use only. CLiK Extra will not treat an active NWS infestation. If a wound is already infested, or an infestation develops after CLiK Extra administration, alternative treatment for the animal is necessary. Treated animals should be kept away from surface waters for at least one hour after treatment due to serious risk to aquatic life. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product Negasunt Powder for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in cattle, swine, goats, sheep, horses, donkeys, domestic hybrid equids, and captive wild, exotic, and zoo mammals. Negasunt Powder is not approved for this use. For use by employees of federal, state, local, and federally recognized tribal agencies, and persons working under their authority and at their direction. Also for use by or on the order of a licensed veterinarian in NWS infested zones and adjacent surveillance zones as defined by the U.S. Department of Agriculture (USDA). Treated animals must not be slaughtered for human consumption within 28 days of the last treatment. A milk discard time has not been established for this product; do not use in animals producing milk for human consumption. A withdrawal period has not been established for this product in pre-ruminating calves; treated calves and calves born to treated cows must not be processed for veal. Do not use in horses intended for human consumption. Do not use in domestic indoor pets (e.g., dogs, cats, rodents, rabbits) nor in residences. Do not use in birds. Do not use in free-ranging wildlife.