Zoetis Receives FDA Approval for Parasite Preventative Treatment for Dogs

Animal health company Zoetis announced the US Food and Drug Administration (FDA) has approved Simparica Trio (sarolaner, moxidectin and pyrantel chewable tablets), which is the first once-monthly chewable tablet in the US that protects from heartworm disease, ticks and fleas, roundworms and hookworms.

This combination product builds on the trusted legacy of Simparica (sarolaner) Chewables. “Today’s approval of Simparica Trio in the United States provides veterinarians with a new and effective combination parasiticide for dogs,” said Catherine A. Knupp, evp and President, Research and Development at Zoetis. “Combining the active ingredients sarolaner, moxidectin and pyrantel delivers a convenient broad-spectrum option for veterinarians to provide to dog owners. This innovation was developed by a global team of Zoetis scientists and continues our commitment to deliver new medicines that are needed by our veterinary customers and the pets in their care.”

Studies that support the approval of Simparica Trio showed 100 percent effectiveness in preventing the development of heartworm disease; that the onset of kill for fleas at four hours after administration and 100 percent efficacy after eight hours; and greater than 90 percent effectiveness against existing tick infestations, adult hookworms and adult roundworms.

“Comprehensive parasite protection is a critical component of every annual wellness exam, and veterinarians should strongly recommend year-round, broad-spectrum protection for all patients,” said Chris Adolph, Senior Veterinary Specialist at Zoetis. “Simparica Trio makes it easier for dog owners to follow their veterinarians’ recommendations for parasite protection because it covers the most common parasites in just one convenient chewable.”

In addition to receiving this approval, Zoetis has received approval for two parasiticide innovations in the US in the past 18 months to help protect dogs and cats from harmful pests. ProHeart 12 (moxidectin), which was approved in July 2019, is the only once-yearly injection to prevent heartworm disease in dogs 12 months of age and older. In November 2018, Zoetis received approval for Revolution Plus (selamectin and sarolaner topical solution), a combination topical product providing 6-in-1 parasite protection against fleas, ear mites, roundworms and certain ticks and hookworms and heartworm disease for cats and kittens as young as eight weeks of age and weighing 2.8 pounds or greater.

Zoetis expects Simparica Trio to be available to veterinary customers by mid-to-late April. Simparica Trio chewable tablets will be available in six tablet strengths for dogs and puppies eight weeks of age and older weighing at least 2.8 pounds.

Important safety information is available here.