Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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