CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1447]

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. 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets.

(a) Specifications. Each tablet contains:

(1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 mg praziquantel;

(2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg praziquantel;

(3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg praziquantel; or

(4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use - (1) Dogs - (i) Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body weight, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis ); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina ), adult hookworm (Ancylostoma caninum ), adult whipworm (Trichuris vulpis ), and adult tapeworm (Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.

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

(2) [Reserved]

[77 FR 4225, Jan. 27, 2012, as amended at 80 FR 18776, Apr. 8, 2015; 83 FR 13635, Mar. 30, 2018; 86 FR 13184, Mar. 8, 2021]