21 CFR §520.43

1. (a)Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
2. (b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
3. (c)Conditions of use—(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).
   1. (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.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.