---
kind: "section"
citation: "21 C.F.R. § 520.1604"
title: "21"
number: "520.1604"
heading: "Oclacitinib."
url: "https://uscodex.org/cfr/21/520.1604"
---

# §520.1604. Oclacitinib.

- (a) **Specifications.** Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
- (b) **Sponsor.** See No. 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023]