Afoxolaner.

§ 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 (lb) (2.5 mg/kilogram (kg)). (2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations ( Ctenocephalides felis ); for the treatment and control of black-legged tick ( Ixodes scapularis ), American dog tick ( Dermacentor variabilis ), lone star tick ( Amblyomma americanum ), and brown dog tick ( Rhipicephalus sanguineus ) 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]