21 C.F.R. § 520.292

Current through October 31, 2024
Section 520.292 - Capromorelin
(a)Specifications. Each milliliter of solution contains:
(1) 30 milligrams (mg) capromorelin; or
(2) 20 mg capromorelin.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Dogs. Use product described in paragraph (a)(1) of this section as follows:
(i)Amount. Administer 3 mg/kg once daily by mouth.
(ii)Indications for use. For appetite stimulation in dogs.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Cats. Use product described in paragraph (a)(2) of this section as follows:
(i)Amount. Administer 2 mg/kg once daily by mouth.
(ii)Indications for use. For management of weight loss in cats with chronic kidney disease.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.292

81 FR 59133 , Aug. 29, 2016, as amended at 85 FR 4207 , Jan. 24, 2020; 86 FR 17063 , Apr. 1, 2021
81 FR 59133, 8/29/2016; as amended at 85 FR 4207, 1/24/2020; 86 FR 17063, 4/1/2021