Section 520.998 - Fluralaner(a)Specifications.(1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner.(2) Each chewable tablet contains 45, 100, 200, 400, or 560 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 with food: (i)Chewable tablets described in paragraph (a)(1) of this section. Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.(ii)Chewable tablets described in paragraph (a)(2) of this section. Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.(2)Indications for use -(i)Chewable tablets described in paragraph (a)(1) of this section. 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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.(ii)Chewable tablets described in paragraph (a)(2) of this section. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis), and the treatment and control of tick infestations [I. scapularis (black-legged tick), D. variabilis (American dog tick), and R. sanguineus (brown dog tick)] for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of A. americanum (lone star tick) infestations for 1 month in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.86 FR 14818, Mar. 19, 2021, as amended at 88 FR 27698, May 3, 2023 86 FR 14818, 3/19/2021; as amended at 88 FR 27698, 5/3/2023