---
kind: "section"
citation: "21 C.F.R. § 516.1287"
title: "21"
number: "516.1287"
heading: "Lotilaner, moxidectin, praziquantel, and pyrantel."
url: "https://uscodex.org/cfr/21/516.1287"
---

# §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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[91 FR 20340, Apr. 16, 2026]

### Source

Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

### Amendments

[91 FR 20340, Apr. 16, 2026]