Lotilaner.

(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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (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 Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. (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 and older, and weighing 2.0 pounds or greater; and for the treatment and control of Ixodes scapularis (black-legged tick) for 1 month in cats and kittens 6 months of age and older, and weighing 2.0 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, as amended at 86 FR 61685, Nov. 8, 2021; 91 FR 20341, Apr. 16, 2026]