§ 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets.

Specifications.(a) 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.

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

(c) [Reserved]

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

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

Limitations.(iii) 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]