§520.2598. Trilostane.
21 C.F.R. § 520.2598
Specifications. Each capsule contains 5, 10, 20, 30, 60, or 120 milligrams (mg) trilostane.
Sponsor. See No. 043264 in § 510.600 of this chapter.
Conditions of use in dogs—
Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.
Indications for use. For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[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; 89 FR 85426, Oct. 28, 2024]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 89 FR 85426, Oct. 28, 2024]