Regulations last checked for updates: Jan 18, 2025

Title 21 - Food and Drugs last revised: Dec 26, 2025
§ 520.1136 - Ilunocitinib.

(a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.

(2) Indications for use. For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

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

[89 FR 95103, Dec. 2, 2024]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.1136