21 CFR § 516.1287 - Lotilaner, moxidectin, praziquantel, and pyrantel.

---
identifier: "/us/cfr/t21/s516.1287"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.1287 - Lotilaner, moxidectin, praziquantel, and pyrantel."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.1287"
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: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
positive_law: false
currency: "2026-04-16"
last_updated: "2026-04-16"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 516.1287 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 at the minimum dosage of 9 mg/pound (mg/lb) (20 mg/kilogram (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 treatment of infestations caused by New World screwworm (*Cochliomyia hominivorax*) larvae (myiasis) 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. It is a violation of Federal law to use this product other than as directed in the labeling.

[91 FR 20340, Apr. 16, 2026]