§ 520.1604 Oclacitinib.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
Specifications.(a) Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) 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.
Indications for use.(2) For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023]
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