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FDA Approves New Indication for Zoetis’ Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets), Now the First and Only Canine Parasiticide to Prevent Flea Tapeworm Infections,

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FDA Approves New Indication for Zoetis’ Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets), Now the First and Only Canine Parasiticide to Prevent Flea Tapeworm Infections,

FDA Approves New Indication for Zoetis’ Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets), Now the First and Only Canine Parasiticide to Prevent Flea Tapeworm Infections,

April 14, 2025

With four new indications across our parasiticides portfolio in just six months, this latest FDA approval reinforces Zoetis’ commitment to innovation to provide broad-spectrum parasite protection for dogs

 

PARSIPPANY, NJ – April 14, 2025 – Zoetis announced that the U.S. Food and Drug Administration (FDA) has approved a new label indication for Simparica Trio to prevent Dipylidium caninum (flea tapeworm) infections by killing Ctenocephalides felis vector fleas in treated dogs. With this approval, Simparica Trio is the only canine combination parasiticide indicated to prevent flea tapeworm infections, at the source, by killing vector fleas before transmission.

“This latest approval of a new indication for Simparica Trio – the second brand label extension in the last six months and the fourth for our parasiticide portfolio – is yet another example of how Zoetis is an industry leader in developing innovative, next-generation parasiticide products and solutions for veterinarians and pet owners,” said Jared Shriver, President, U.S. Operations at Zoetis. “Since the FDA approval of Simparica Trio in 2020, we have continued to build on the expansive body of research demonstrating the utility of this important preventative. With Simparica Trio, we are committed to delivering the comprehensive protection that every dog deserves.”

Simparica Trio is the No. 1 veterinarian-prescribed combination parasiticide for dogs and has been used by more than 15 million dogs in its five years on the market.[i] Simparica Trio was the first product to provide all-in-one protection for dogs against heartworm disease, ticks and fleas, roundworms, hookworms, and now prevents flea tapeworm infections in a single monthly chewable.* It is the only combination product FDA-approved for six species of ticks that also prevents infections that may cause Lyme disease, by killing deer ticks. Simparica Trio starts killing fleas within four hours and is a simple-to-give, highly palatable monthly chewable that can be given with or without a meal, with no impact on its effectiveness.

“The best and easiest way to safeguard our pets from parasites is by taking preventative measures to help reduce or eliminate illness,” said Tara Bidgood, DVM, PhD, DACVCP, Vice President, Head of Veterinary Professional Services and Medical Affairs, U.S. Independent Petcare at Zoetis. “Preventing diseases like flea tapeworm infections with this latest FDA approval for Simparica Trio, helps protect our dogs’ health but also helps strengthen the unique bond dogs share with their owners.” 

About Flea Tapeworms 

Flea tapeworms (Dipylidium caninum) are flat parasites found in the intestines of dogs that can grow up to 11 inches long. They are transmitted to dogs when fleas carrying tapeworm eggs are accidentally swallowed. Controlling fleas significantly reduces the likelihood of flea tapeworm infection. Simparica Trio protects against flea tapeworm infections, at the source, by killing Ctenocephalides felis vector fleas before transmission. 

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.

About Zoetis 

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $9.3 billion in 2024 with approximately 13,800 employees. For more information, visit www.zoetis.com.

*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), lxodes 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 lxodes scapularis vector ticks.

All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted. © 2025 Zoetis Services LLC. All rights reserved. STR-00792

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