(a) Specifications. Each chewable tablet contains 112.5, 250, 500, 1000, or 1400 milligrams (mg) fluralaner.

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

(c) Conditions of use in dogs—(1) Amount. Administer orally as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg per pound (/lb) (25 mg per kilogram) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.

(2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.

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

[79 FR 37619, July 2, 2014]