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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1286]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1286 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), 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]

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