Section 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 84 FR 8972, 3/13/2019; 84 FR 39182, 8/9/2019; 88 FR 55563, 8/16/2023