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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.43]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.43 Afoxolaner.

(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.

(b) Sponsor. See No. 000010 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.

[78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019]

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