§ 520.1286. Lotilaner.
291 words·~1 min read·
/us/cfr/t21/s§ 520.1286·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]