Elanco's CLiK Extra Wound Spray Receives FDA Emergency Use Authorization for Application on or Around Wounds for Prevention of New World Screwworm in Variety of Livestock and Captive and Captured Wildlife Species

Vigilance and early intervention are key to minimizing animal injury and limiting the parasite's spread, according to Elanco's technical experts

Emergency Use Authorization for Elanco's CLiK Extra provides livestock producers with a vital tool in the prevention of New World screwworm infestations.
Elanco also offers producers Negasunt^®Powder (coumaphos, propoxur, and sulfanilamide topical powder) and Tanidil^®, which received emergency authorizations earlier this year, as well as EPA-registered Catron™ IV.
Elanco's technical experts emphasize "eyes on livestock" and early intervention are the most effective ways to minimize animal injury and prevent the parasite's spread.

Elanco Animal Health Incorporated (NYSE: ELAN) today announced it has 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.

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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.ⁱUnlike 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.ⁱⁱ

"Education is a producer's most powerful tool in this fight," says Dr. M. Wayne Ayers, DVM, Senior Technical Consultant for Elanco. Ayers advises that staying informed through trusted experts and knowing exactly where the fly is active are top priorities.

"The second pillar of protection is prevention," he says. "By checking animals as often as possible and using appropriate wound care for any noticeable lesions or sores, producers can potentially avoid conditions that might lead to New World screwworm larvae infestations. Speed is crucial. It minimizes injury to the animal, lowers the risk of death, and most importantly, prevents the next generation of flies from completing their lifecycle and expanding the outbreak."

"Now that New World screwworm is back in the United States, we want producers to know they don't have to figure this out alone," Ayers continued. "Elanco is here to help. We can look at your current situation to help you see where you can sharpen your protocols and ensure you're reaching for the right product at exactly the right moment to protect your animals."

CLiK Extra will be available for purchase by animal health professionals, livestock producers and those managing captive and captured wildlife through standard product channels.

To learn more about New World screwworm using the following resources:

Emergency Use Authorization of CLiK Extra (dicyclanil topical suspension) Wound Spray for New World Screwworm (NWS)

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.

For additional information on the EUA and for complete safety information, please refer to the CLiK Extra NWS Fact Sheet.

Limitations of Authorized Use
It is a violation of Federal law to use this drug product other than as directed in the fact sheet.

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.

Additional Important Safety Information
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.

Emergency Use Authorization of Negasunt Powder (coumaphos, propoxur, and sulfanilamide topical powder) for New World Screwworm (NWS)

WARNING: Neurotoxicity. Read full Fact Sheet for complete information.

- Coumaphos and propoxur can cause neurotoxicity. May be fatal if swallowed. May be fatal if inhaled. Harmful if absorbed through skin. Causes moderate eye irritation. Do not breathe dust. Avoid contact with eyes, skin, or clothing.
- Use only with appropriate personal protective equipment (PPE): coveralls worn over long-sleeve shirt and long pants, shoes, socks, and protective eyewear; chemical-resistant gloves made of barrier laminate, butyl rubber (≥ 14 mils), nitrile rubber (≥14 mils), neoprene rubber (>14 mils), natural rubber (≥14 mils), polyethylene, polyvinyl chloride (PVC) ≥14 mils, or Viton (>14 mils); and a minimum of a NIOSH-approved elastomeric half mask respirator consisting of protection factor (PF) 10 fitted with organic vapor (OV) cartridges and combination R or P filters; or a NIOSH-approved gas mask with OV canisters; or a NIOSH-approved powered air purifying respirator with OV cartridges and combination HE filters.
- This product is toxic to mammals, birds, fish, and aquatic invertebrates.

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).

For additional information on the EUA and for complete safety information, please refer to the Negasunt Powder NWS Fact Sheet.

Limitations of Authorized Use

It is a violation of federal law to use this drug product other than as directed in the authorized Fact Sheet.

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.

To avoid overexposure, each individual person cannot treat more than 3 large wounds (>2 inches diameter) a day or more than 30 small superficial wounds (≤2 inches diameter) a day (or an equivalent thereof) with Negasunt Powder or any other coumaphos-containing products.

Negasunt Powder is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Negasunt Powder 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.

Federal law prohibits the extra-label use of this drug.

Additional Important Safety Information

Not for use in humans. Keep out of reach of children. Only handlers wearing required PPE may be in the area during application. Do not apply in a confined, non-ventilated area; provide thorough ventilation. Call a poison control center or doctor immediately for treatment advice if Negusant Powder is swallowed, inhaled, on skin or clothing, or in eyes. Sulfonamides are contraindicated in animals that are hypersensitive to them and in animals with severe renal or hepatic impairment. For external use only on animals. Do not contaminate water, feed, troughs, feed handling equipment, or milk or meat handling equipment. Use with caution in very young, weak, or debilitated animals. In the case of overdose, treat with atropine sulfate or pralidoxine chloride (2-PAM) as soon as possible. The most common adverse reactions associated with organophosphate and carbamate toxicity in animals include frequent urination and defecation, muscle twitching, and watering eyes.

Important Information about Tanidil

Tanidil™ is an unregistered product for distribution and use only under a Section 18 emergency exemption. The Section 18 labeling must be in the possession of the user at the time of pesticide application. This product may only be used to prevent or control New World screwworm in and on animal wounds on labeled animal host species.

For use only by federal, state, local, and federally recognized tribal agencies, and persons working under their supervision; personnel at quarantine stations and areas; veterinarians; veterinarians or certified applicators at livestock and game facilities, zoos, wildlife facilities, animal rehabilitation centers; and wildlife professionals.

Read the entire label. This product must be used strictly in accordance with this label's precautionary statements and use directions, as well as with all applicable state and federal laws and regulations. Please visit the Tanidil fact sheet for more information.

Use Period: This exemption is effective on April 27, 2026 and expires on April 27, 2029. No applications of Tanidil may be made under the emergency exemption before its effective date or after its expiration date.

ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at www.elanco.com.

PM-US-26-1426

ⁱ USDA Confirms Presence of New World Screwworm in the United States | Animal and Plant Health Inspection Service
ⁱⁱ New World Screwworm." www.aphis.usda.gov, www.aphis.usda.gov/livestock-poultry-disease/cattle/ticks/screwworm.

Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com
Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com

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