21 C.F.R. § 520.2086

Current through October 31, 2024
Section 520.2086 - Sarolaner
(a)Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Amount. Administer orally once a month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).
(2)Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.2086

81 FR 22523 , Apr. 18, 2016, as amended at 82 FR 12169 , Mar. 1, 2017; 86 FR 61685 , Nov. 8, 2021
81 FR 22523, 4/18/2016; as amended at 82 FR 12169, 3/1/2017; 86 FR 61685, 11/8/2021