- (a) Specifications. Each sustained-release tablet contains 0.4, 1.2, or 2.4 milligrams (mg) sirolimus.
- (b) Sponsor. See No. 086169 in § 510.600(c) of this chapter.
- (c) Conditions of use in cats—(1) Amount. Administer orally once weekly at a dose of 0.3 mg/kilogram of bodyweight.
- (2) Indications for use. For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).
- (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[90 FR 19624, May 9, 2025]