Afoxolaner, moxidectin, and pyrantel.

(a) Specifications. 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). (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. 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. (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (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 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. [88 FR 84699, Dec. 6, 2023, as amended at 90 FR 6799, Jan. 21, 2025; 90 FR 40969, Aug. 22,2025; 91 FR 41559, July 7, 2026]