21 CFR § 520.1287 - Lotilaner, moxidectin, praziquantel, and pyrantel.

---
identifier: "/us/cfr/t21/s520.1287"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1287 - Lotilaner, moxidectin, praziquantel, and pyrantel."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1287"
section_name: "Lotilaner, moxidectin, praziquantel, 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"
---


# 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.

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

(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);

(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);

(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);

(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or

(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 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*), hookworm (fourth stage larvae, immature adult, and adult *Ancylostoma caninum* and adult *Uncinaria stenocephala*), and tapeworm (*Dipylidium caninum, Taenia pisiformis,* and *Echinococcus granulosus*) infections.

 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), *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 and older, and weighing 3.3 pounds or greater.

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

[90 FR 6800, Jan. 21, 2025, as amended at 90 FR 40969, Aug. 22, 2025]