21 CFR § 520.1447 - Milbemycin oxime, lufenuron, and praziquantel tablets.

---
identifier: "/us/cfr/t21/s520.1447"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1447 - Milbemycin oxime, lufenuron, and praziquantel tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1447"
section_name: "Milbemycin oxime, lufenuron, and praziquantel tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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]