21 C.F.R. § 520.522 Cyclosporine.
Title 21 - Food and Drugs
(a) Specifications. Each capsule contains 10, 25, 50, or 100 milligrams (mg) cyclosporine. (b) Sponsor. See No. 058198 in §510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use in dogs—(1) Amount. 5 mg per kilogram of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect. (2) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds body weight. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 54804, Sept. 19, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.522 Cyclosporine.
