§ 520.1445 Milbemycin oxime and praziquantel.

Specifications.(a) 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.

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

Conditions of useDogsAmount.(c) —(1) —(i) 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.

Indications for use.Dirofilaria immitisToxocara canis, Toxascaris leoninaAncylostoma caninumTrichuris vulpisTaenia pisiformis, Echinococcus multilocularis, E. granulosus,Dipylidium caninum(ii) For the prevention of heartworm disease caused by 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 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017]