(a) Specifications. Each chewable tablet contains:

(1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or

(2) For use in cats: 12 or 48 mg lotilaner.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).

(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg).

(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis) for 1 month in cats and kittens 8 weeks of age or older and weighing 2 pounds or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18119, Apr. 1, 2020]