21CFR520.2086

(a) Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter . (c) Conditions of use in dogs — (1) Amount. Administer orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg). (2) Indications for use. Kills adult fleas, and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( 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 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.