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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.522]



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

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.522 Cyclosporine.

(a) Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.

(2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 058198 for use of products described in paragraph (a) as in paragraph (d) of this section.

(2) No. 026637 for use of product described in paragraph (a)(1) as in paragraph (d)(1) of this section.

(3) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1) of this section.

(c) [Reserved]

(d) Conditions of use - (1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow:

(i) Amount. Administer 5 mg per kilogram (mg/kg) 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.

(ii) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds.

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

(2) Cats. Use the solution described in paragraph (a)(2) of this section as follow:

(i) Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.

(ii) Indications for use. For the control of feline allergic dermatitis in cats at least 6 months of age and weighing at least 3 pounds.

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

[68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011; 84 FR 12493, Apr. 2, 2019; 86 FR 17063, Apr. 1, 2021]

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