21 CFR § 520.2086 - Sarolaner.

---
identifier: "/us/cfr/t21/s520.2086"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2086 - Sarolaner."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2086"
section_name: "Sarolaner."
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"
---


# 520.2086 Sarolaner.

(a) *Specifications.* Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg).

(2) *Indications for use.* Kills adult fleas, and is indicated for the treatment and prevention of flea infestations (*Ctenocephalides felis*), and the treatment and control of tick infestations (*Amblyomma americanum* (lone star tick), *Amblyomma maculatum* (Gulf Coast tick), *Dermacentor variabilis* (American dog tick), *Ixodes scapularis* (black-legged tick), *Rhipicephalus sanguineus* (brown dog tick), and *Haemaphysalis longicornis* (Asian longhorned tick)) for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. For the prevention of *Borrelia burgdorferi* infections as a direct result of killing *Ixodes scapularis* vector ticks.

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

[81 FR 22523, Apr. 18, 2016, as amended at 82 FR 12169, Mar. 1, 2017; 86 FR 61685, Nov. 8, 2021; 90 FR 6800, Jan. 21, 2025]