§ 520.1286 Lotilaner.

Specifications.(a) 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.

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

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

Indications for use.Ctenocephalides felisAmblyomma americanumDermacentor variabilisIxodes scapularisRhipicephalus sanguineusHaemaphysalis longicornisBorrelia burgdorferiIxodes scapularis(ii) Kills adult fleas, and for the treatment and prevention of flea infestations (), and the treatment and control of tick infestations ( (lone star tick), (American dog tick), (black-legged tick), (brown dog tick), and (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. For the prevention of infections as a direct result of killing vector ticks.

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

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

Indications for use.Ctenocephalides felisIxodes scapularis(ii) Kills adult fleas, and for the treatment and prevention of flea infestations () for 1 month in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds or greater; and for the treatment and control of (black-legged tick) for 1 month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater.

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

[85 FR 18119, Apr. 1, 2020, as amended at 86 FR 61685, Nov. 8, 2021; 91 FR 20341, Apr. 16, 2026]