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21 CFR 520.2086

§ 520.2086 Sarolaner.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 520.2086, § 520.2086 Sarolaner, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87302
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.