Title 21

SECTION 520.1604

520.1604 Oclacitinib.

§ 520.1604 Oclacitinib.

(a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.

(2) Indications for use. For 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.

[78 FR 42007, July 15, 2013]

---