subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.2075"
section_subject: "Robenacoxib."
cfr_reference: "21 CFR 520.2075"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
(b)Sponsors. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Dogs—(i) Amount. Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Cats—(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.