21 CFR § 520.1286 - Lotilaner.

---
identifier: "/us/cfr/t21/s520.1286"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1286 - Lotilaner."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1286"
section_name: "Lotilaner."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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 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]