CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.522—Cyclosporine.

520.522—Cyclosporine.

(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.

Code of Federal Regulations

[68 FR 54804, Sept. 19, 2003]