§ 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.

Specifications.(a) Each chewable tablet contains:

(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);

(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);

(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);

(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or

(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).

Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.

Conditions of useAmount.(c) —(1) Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

Indications for use.Dirofilaria immitisToxocara caniToxascaris leoninaAncylostoma caninumUncinaria stenocephalaDipylidium caninum, Taenia pisiformis,Echinococcus granulosusCtenocephalides felisAmblyomma americanumDermacentor 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 s and adult ), hookworm (fourth stage larvae, immature adult, and adult and adult ), and tapeworm ( and ) infections. 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), (American dog tick), (black-legged tick), (brown dog tick), and (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 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.

[90 FR 6800, Jan. 21, 2025, as amended at 90 FR 40969, Aug. 22, 2025; 91 FR 20341, Apr. 16, 2026]