§ 520.35 Afoxolaner, moxidectin, and pyrantel.

Specifications.(a) Each chewable tablet contains:

(1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel (as pamoate salt);

(2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel (as pamoate salt);

(3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as pamoate salt);

(4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as pamoate salt); or

(5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as pamoate salt).

Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.

Conditions of useAmount.(c) —(1) Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes.

Indications for use.Dirofilaria immitisAncylostoma caninum, Ancylostoma braziliense,Uncinaria stenocephalaToxocara canisToxascaris leoninaCtenocephalides felisIxodes scapularisRhipicephalus sanguineusDermacentor variabilisAmblyomma americanumHaemaphysalis longicornisBorrelia burgdorferiIxodes scapularis(2) For the prevention of heartworm disease caused by and for the treatment and control of adult hookworm ( and ) and roundworm ( and ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations () and the treatment and control of (black-legged tick), (brown dog tick), (American dog tick), (lone star tick), and (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight 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.

[88 FR 84699, Dec. 6, 2023, as amended at 90 FR 6799, Jan. 21, 2025; 90 FR 40969, Aug. 22,2025]