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: 21CFR520.1445]

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. 520.1445 Milbemycin oxime and praziquantel.

(a) Specifications. Each chewable tablet contains:

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

(2) 5.75 mg milbemycin oxime and 57 mg praziquantel;

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

(4) 23 mg milbemycin oxime and 228 mg praziquantel.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs - (i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina ), adult hookworm (Ancylostoma caninum ), adult whipworm (Trichuris vulpis ), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum ) 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 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017]