CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.960]

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. 520.960 Flumethasone.

(a) Specifications. Each tablet contains 0.0625 milligram of flumethasone.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses.

(ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in divided doses.

(2) Indications for use - (i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis.

(ii) Dogs and cats: It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

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

[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014]