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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: 21CFR520.2090]



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. 520.2090 Sarolaner, moxidectin, and pyrantel.

(a) Specifications. Each chewable tablet contains:

(1) 3.0 mg sarolaner, 0.06 mg moxidectin, and 12.5 milligrams (mg) pyrantel (as pamoate salt);

(2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as pamoate salt);

(3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as pamoate salt);

(4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as pamoate salt);

(5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as pamoate salt); or

(6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as pamoate salt).

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer orally, once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 [micro]g/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

(2) Indications for use. Prevents heartworm disease caused by Dirofilaria immitis, kills adult fleas (Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick), and the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala ) infections for 1 month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 45307, July 28, 2020]

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