Zoetis Receives Emergency Use Authorization for Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets) for Treatment of New World Screwworm Infestations in Dogs and Puppies

• Expands the solutions available to veterinarians to help address New World screwworm and gives added confidence for pet owners whose dogs and puppies are already receiving Simparica Trio
• Milestone demonstrates Zoetis' coordinated multi-species response to address New World screwworm across both companion animals and livestock

PARSIPPANY, N.J.--(BUSINESS WIRE)--Zoetis Inc. today announced that Simparica Trio has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Larvae of Cochliomyia hominivorax, commonly called New World screwworm (NWS), feed on living tissues, such as open wounds, of animals including livestock, wildlife and pets, and can inflict damage, pain and even death if not treated.

As New World screwworm continues to threaten the U.S.¹ -- recently prompting several states to issue formal orders requiring treatment of domestic animals as part of cross-border animal movement from infested areas -- Zoetis is closely monitoring the situation and is committed to helping veterinarians and dog owners be prepared with solutions. Under an EUA, the FDA authorizes the use of a medication in an emergency to treat or prevent life-threatening diseases or conditions when certain criteria are met.

“At Zoetis, our highest priority is protecting the health and well-being of animals,” said Abhay Nayak, EVP and President, U.S. Commercial Operations at Zoetis. “The Emergency Use Authorization for Simparica Trio provides an important new tool in the fight against New World screwworm, a devastating parasite that can cause severe suffering in dogs. With this milestone, Simparica Trio helps simplify parasite protection for dogs with a single monthly chew—supporting both routine control and New World screwworm response needs.”

“We are deeply committed to supporting our customers with trusted, science-driven solutions—especially when rapid response and preparedness on key public health issues are critical. This Emergency Use Authorization for Simparica Trio builds on Zoetis’ expanding, multi-species set of solutions to help address New World screwworm across both companion animals and livestock,” Nayak continued. “Zoetis remains dedicated to advancing animal health and delivering the confidence our customers rely on, backed by Zoetis’ science, quality and manufacturing scale – so more animals can be protected, more consistently.”

Simparica Trio was the first product FDA-approved to provide all-in-one protection for dogs against heartworm disease, ticks and fleas, roundworms, hookworms, and prevents flea tapeworm infections by killing fleas in a single monthly chewable. It is FDA-approved to kill six species of ticks, including the Gulf Coast tick – providing comprehensive tick protection. While found all over the nation, the Gulf Coast tick is native to Southern U.S. states, including Texas.

Pet owners are encouraged to work closely with their veterinarian if they have any concerns about New World screwworm or other parasites. Reports of any suspicious wounds, maggots, or infestations should be made to a local veterinarian, state animal health official or the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). USDA APHIS animal health contacts can be found at https://www.aphis.usda.gov/contact/animal-health.

As the leading animal health company, Zoetis has long supported a One Health approach to emerging and transboundary infectious diseases and has a strong track record of quickly developing innovative solutions to provide veterinarians and animal owners with the right mix of tools to prevent, control and treat disease in animals.

IMPORTANT SAFETY INFORMATION for Simparica Trio
Use with caution in dogs with a history of seizures. Simparica Trio contains sarolaner, a member of the isoxazoline class which has been associated with neurologic adverse reactions including tremors, ataxia, and seizures in dogs with or without a history of neurologic disorders. The safe use of Simparica Trio has not been evaluated in breeding, pregnant, or lactating dogs. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. See Full Prescribing Information at SimparicaTrioPI.com.

Treatment of New World screwworm in Other Species
In addition to the EUA for Simparica Trio, Zoetis offers Dectomax^®-CA1 Injectable (doramectin injection), the only nonprescription conditionally approved parasite control product labeled for prevention and treatment of infestations caused by NWS larvae in cattle and for prevention of reinfestation for 21 days. This conditional approval applies to beef cattle, female dairy cattle less than 20 months of age, pregnant beef cows, newborn calves and bulls. Dectomax-CA1 is not for use in calves to be processed for veal. Dectomax-CA1 is not for use in female dairy cattle 20 months of age or older, except under the conditions of the Emergency Use Authorization (EUA) granted on May 19, 2026.

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the use of the approved/conditionally approved products Dectomax/Dectomax-CA1 for the following indications:

• The prevention and treatment of infestations caused by Cochliomyia hominivorax larvae (myiasis) in dairy cattle (lactating dairy cows, dry dairy cows, and replacement dairy heifers 20 months of age and older), except for calves to be processed for veal.
• The prevention of infestations caused by C. hominivorax larvae (myiasis) in swine, sheep except for lactating sheep, and deer.
• The prevention of infestations caused by C. hominivorax larvae (myiasis) in horses 1 year old and older.

Early detection of New World screwworm and rapid response are crucial to protecting the health of companion animals and livestock.

Emergency Use Authorization for Simparica Trio for New World Screwworm
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Simparica Trio (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Simparica Trio is not approved for this use.

Simparica Trio is approved for other uses in dogs and puppies.

For additional information on the EUA, please refer to the Simparica Trio EUA Fact Sheet.

Limitations of Authorized Use
Simparica Trio (sarolaner, moxidectin, and pyrantel chewable tablets) is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Simparica Trio (sarolaner, moxidectin, and pyrantel chewable tablets) 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.

Approved Indications for Simparica Trio
Simparica Trio is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Simparica Trio kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica Trio is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

About Zoetis
Zoetis is the world’s leading animal health company, driven by a singular purpose: to nurture our world and humankind by advancing care for animals. With a legacy of nearly 75 years, Zoetis continues to pioneer ways to predict, prevent, detect, and treat animal illness, supporting veterinarians, livestock producers, and pet owners in over 100 countries. We integrate deep scientific expertise, data-driven R&D, advanced manufacturing, and commercial excellence to deliver meaningful innovation across medicines, vaccines, diagnostics, biopharmaceuticals, and digital solutions. Guided by our vision to be the most trusted and valued animal health company, Zoetis is committed to setting new standards for the future of animal care through innovation, customer obsession, and purpose-driven colleagues. To learn more, visit Zoetis.com.

Please refer to the following fact sheets for additional information:
EUA - Simparica Trio Fact Sheet
EUA - Dairy Cattle, Swine, Sheep and Deer Fact Sheet
EUA - Horse Fact Sheet
For more information on NWS, visit FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies

Dectomax-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under NADA 141-616.
Important Information:
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Dectomax-CA1 Injectable (Cattle only), as authorized under the Conditional Approval for use against New World screwworm, has a 35-day pre-slaughter withdrawal period. Do not use in calves to be processed for veal. Do not use in female dairy cattle 20 months of age or older, except under the conditions of the Emergency Use Authorization. Use in dogs may result in fatalities.
Dectomax/Dectomax-CA1 Injectable Emergency Use Authorization, authorized for the duration of the emergency declaration, does not provide full or conditional approval, but the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA) has determined that Dectomax/Dectomax-CA1 may be effective and safe. Dectomax/Dectomax-CA1 Injectable, as authorized under the Emergency Use Authorization for use against New World screwworm, has a 35-day pre-slaughter withdrawal period for lactating dairy cattle, dry dairy cattle, replacement dairy heifers, sheep and deer, and a 24-day pre-slaughter withdrawal period for swine. Treated calves and calves born to treated cows should not be processed for veal. Withhold milk from dairy cattle for 468 hours (19.5 days) after treatment has ended. Not for use in lactating sheep. Not for use in horses less than 1 year of age.

DISCLOSURE NOTICES
Forward-Looking Statements: This press release contains forward-looking statements which reflect the current views of Zoetis with respect to regarding products, product approvals or licenses, products under development and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our most recent Annual Report on Form 10-K, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.

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¹ APHIS. Current Status of New World Screwworm | Screwworm.gov Accessed 6/3/26.