21 CFR § 520.2090 - Sarolaner, moxidectin, and pyrantel.

---
identifier: "/us/cfr/t21/s520.2090"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2090 - Sarolaner, moxidectin, and pyrantel."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2090"
section_name: "Sarolaner, moxidectin, and pyrantel."
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"
---


# 520.2090 Sarolaner, moxidectin, and pyrantel.

(a) *Specifications.* Each chewable tablet contains:

(1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt);

(2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as pamoate salt);

(3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as pamoate salt);

(4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as pamoate salt);

(5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as pamoate salt); or

(6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as pamoate salt).

(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 dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

(2) *Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis* and for the treatment and control of roundworm (immature adult and adult *Toxocara canis* and adult *Toxascaris leonina*) and hookworm (L4, immature adult, and adult *Ancylostoma caninum* and adult *Uncinaria stenocephala*) infections. Kills adult fleas (*Ctenocephalides felis*) and is indicated for the treatment and prevention of flea infestations, the prevention of *Dipylidium caninum* (tapeworm) infections as a direct result of killing *Ctenocephalides felis* vector fleas on the treated dog, and the treatment and control of tick infestations with *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 one month in dogs and puppies 8 weeks of age and 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.

[85 FR 45307, July 28, 2020, as amended at 86 FR 57997, Oct. 20, 2021; 87 FR 17945, Mar. 29, 2022; 89 FR 95103, Dec. 2, 2024; 90 FR 6800, Jan. 21, 2025; 90 FR 40970, Aug. 22, 2025]