Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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]

Where this section sits in the code

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

(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]

Collected 2026-08-27T02:24:47Z. Source file · JSON

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