Zoetis receives FDA approval for monthly flea-tick chewable

Zoetis receives FDA approval for monthly flea-tick chewable

New drug in isoxazoline class lasts 35 days without drop in efficacy, company reports.
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Feb 25, 2016
By dvm360.com staff

Zoetis announced Feb. 25 that the U.S. Food and Drug Administration (FDA) has approved Simparica (sarolaner) Chewables to kill adult fleas and prevent flea infestations, as well as treat and control tick infestations due to the Lone Star tick, the Gulf Coast tick, the American dog tick and the brown dog tick. Simparica is approved for use in dogs 6 months of age or older weighing 2.8 pounds or more. In a single-dose chewable tablet, once-monthly Simparica’s peak performance lasts for 35 days without losing efficacy at the end of the month, according to product testing.

The active ingredient in Simparica is sarolaner, a new ectoparasiticide in the isoxazoline class. Simparica was field-safety and efficacy tested on more than 900 dogs over a two- or three-month period. The dogs in these studies included both genders and many different breeds.

Clinical studies showed that sarolaner started killing fleas in three hours, virtually eliminated fleas within eight hours, and reduced the number of live fleas from ≥96.2% to 100% through day 35. Simparica’s rapid onset of action means that fleas are killed before they have a chance to lay eggs, preventing home infestations and providing relief to dogs suffering with flea allergy dermatitis, product developers say. Studies also showed that Simparica started killing ticks in eight hours, remaining ≥96.9% effective for 35 days against weekly re-infestations.

Simparica comes in a liver-flavored chewable tablet designed to be highly palatable. Zoetis expects to make Simparica available to veterinarians and pet owners in March. The tablets will be available in 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg dosage strengths.

For more information, visit zoetisUS.com/Simparica.