§ 520.2086 Sarolaner.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.(a) Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg).
Indications for use.Ctenocephalides felisAmblyomma americanumAmblyomma maculatumDermacentor variabilisIxodes scapularisRhipicephalus sanguineusHaemaphysalis longicornisBorrelia burgdorferiIxodes scapularis(2) Kills adult fleas, and is indicated for the treatment and prevention of flea infestations (), and the treatment and control of tick infestations ( (lone star tick), (Gulf Coast tick), (American dog tick), (black-legged tick), (brown dog tick), and (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 infections as a direct result of killing vector ticks.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 22523, Apr. 18, 2016, as amended at 82 FR 12169, Mar. 1, 2017; 86 FR 61685, Nov. 8, 2021; 90 FR 6800, Jan. 21, 2025]
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