CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.2598]

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

Sec. 520.2598 Trilostane.

(a) Specifications. Each capsule contains 5, 10, 30, 60, or 120 milligrams (mg) trilostane.

(b) Sponsor. See No. 043264 in § 510.600 of this chapter.

(c) Conditions of use in dogs - (1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.

(2) Indications for use. For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

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

[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015; 87 FR 58962, Sept. 29, 2022]