Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 520.43 - Afoxolaner.

(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.

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

(c) Conditions of use—(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).

(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and 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.

[78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019; 88 FR 55563, Aug. 16, 2023]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.43