subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.43"
section_subject: "Afoxolaner."
cfr_reference: "21 CFR 520.43"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
(b)Sponsor. See No. 050604 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).
(2)Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), lone star tick (Amblyomma americanum), and brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and 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.