Featured at VMX 2025: Zoetis Announces New FDA Label Approvals for Simparica and Revolution Plus

FDA approves new indications for Simparica Trio^® (sarolaner, moxidectin, and pyrantel chewable tablets), Simparica^® (sarolaner) Chewables, and Revolution^® Plus (selamectin and sarolaner topical solution)

Zoetis announced that the U.S. Food and Drug Administration (FDA) has approved a new label indication for Simparica Trio and Simparica Chewables for the treatment and control of infestations with Haemaphysalis longicornis (Asian longhorned tick) in dogs eight weeks of age and older weighing 2.8 pounds and greater.

With the addition of the new claim, Simparica Trio has the broadest tick coverage of any preventative in its class and continues to be the leading combination parasiticide for dogs, treating 13 million dogs and counting since its 2020 launch.¹ Simparica also received approval for the treatment and control of infestations with Haemaphysalis longicornis (Asian longhorned tick) in dogs six months of age and older weighing 2.8 pounds and greater.

 

 

“Ticks pose a significant health risk to pets. Ensuring readily available and efficient tick control options is crucial to safeguarding pets’ health, ultimately enabling them to enjoy more quality time with their owners,” says Mason Reichard, PhD, Field Parasitologist at Zoetis. “Expanding the efficacy claim of Simparica Trio to include treatment and control of infestations of the Asian longhorned tick offers veterinarians a valuable resource to combat this invasive tick species and gives dog owners peace of mind.”

 

The FDA also approved a new label indication for Revolution Plus for the prevention of Dipylidium caninum (tapeworm) infections at the source, as a direct result of killing Ctenocephalides felis vector fleas on the treated cat for one month in cats and kittens eight weeks and older and weighing 2.8 pounds or greater. Revolution Plus is the most-prescribed parasite preventative for cats,² and with the approval of the new claim, it is the only feline combination preventative indicated to prevent flea tapeworm infections at the source, by killing vector fleas before transmission.

Simparica Trio and Revolution Plus Deliver on Zoetis’ Commitment to Innovation in Parasiticides

The evolution of Simparica Trio, Simparica Chewables, and Revolution Plus indications is just the latest example of Zoetis’ commitment to next generation parasiticide products and solutions for veterinarians. Simparica Trio was the first product introduced to provide all-in-one protection for dogs against heartworm disease, ticks & fleas, roundworms & hookworms in a single monthly chewable.* It is the only combination product FDA-approved to treat and control infestations for six species of ticks, as well as prevent infections that may cause Lyme disease, by killing deer ticks. Simparica Trio delivers comprehensive protection that every dog deserves.

With the new label extension, Revolution Plus offers broad protection against fleas, flea tapeworm infections (by killing vector fleas), ticks, ear mites, roundworms, hookworms, and heartworm disease.^†

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.comThis links to a pdf file.

IMPORTANT SAFETY INFORMATION FOR REVOLUTION PLUS

The safe use of Revolution Plus has not been established in kittens less than 8 weeks old or in breeding, pregnant or lactating cats. Reported side effects in clinical trials included lethargy and anorexia. Use with caution in cats with a history of neurologic disorders. Revolution Plus contains sarolaner, a member of the isoxazoline class which has been associated with neurologic adverse reactions, such as tremors, ataxia, and seizures in cats with or without a history of neurologic disorders. In humans, Revolution Plus may be irritating to skin and eyes. See full Prescribing Information at RevolutionPlusPI.comThis links to a pdf file.

IMPORTANT SAFETY INFORMATION FOR SIMPARICA

Simparica is for use only in dogs 6 months of age and older. Simparica, which contains sarolaner, a member of the isoxazoline class, may cause neurologic signs such as tremors, unsteadiness and/or seizures in dogs with or without a history of neurologic disorders. Simparica has not been evaluated in pregnant, breeding, or lactating dogs. The most common adverse reactions in clinical trials were vomiting and diarrhea. See full Prescribing Information at SimparicaPI.comThis links to a pdf file

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