§ 524.1001 - Fluralaner and moxidectin.

§ 524.1001 Fluralaner and moxidectin.

(a) Specifications. Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin.

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

(c) Conditions of use -

(1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th fourth-stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th fourth-stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick) and , Dermacentor variabilis (American dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10, 2023]