§ 520.2090 Sarolaner, moxidectin, and pyrantel.

Specifications.(a) Each chewable tablet contains:

(1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt);

(2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as pamoate salt);

(3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as pamoate salt);

(4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as pamoate salt);

(5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as pamoate salt); or

(6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as pamoate salt).

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 dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

Indications for use.Dirofilaria immitisToxocara canisToxascaris leoninaAncylostoma caninumUncinaria stenocephalaCtenocephalides felisDipylidium caninumCtenocephalides felisAmblyomma americanumAmblyomma maculatumDermacentor variabilisIxodes scapularisRhipicephalus sanguineusHaemaphysalis longicornisBorrelia burgdorferiIxodes scapularis(2) For the prevention of heartworm disease caused by and for the treatment and control of roundworm (immature adult and adult and adult ) and hookworm (L4, immature adult, and adult and adult ) infections. Kills adult fleas () and is indicated for the treatment and prevention of flea infestations, the prevention of (tapeworm) infections as a direct result of killing vector fleas on the treated dog, and the treatment and control of tick infestations with (lone star tick), (Gulf Coast tick), (American dog tick), (black-legged tick), (brown dog tick), and (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and 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.

[85 FR 45307, July 28, 2020, as amended at 86 FR 57997, Oct. 20, 2021; 87 FR 17945, Mar. 29, 2022; 89 FR 95103, Dec. 2, 2024; 90 FR 6800, Jan. 21, 2025; 90 FR 40970, Aug. 22, 2025]