21 CFR § 520.928 - Firocoxib tablets.

---
identifier: "/us/cfr/t21/s520.928"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.928 - Firocoxib tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.928"
section_name: "Firocoxib tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.928 Firocoxib tablets.

(a) *Specifications.* (1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.

(2) Each tablet contains 57 mg firocoxib.

(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter as follows:

(1) Nos. 000010, 013744, 055246, 055529, and 086101 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and

(2) Nos. 000010 and 055246 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section.

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery.

(ii) *Indications for use.* For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.

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

(2) *Horses*—(i) *Amount.* Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days.

(ii) *Indications for use.* For the control of pain and inflammation associated with osteoarthritis.

(iii) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, 2008; 81 FR 67151, Sept. 30, 2016; 87 FR 58961, Sept. 29, 2022; 88 FR 14897, Mar. 10, 2023; 88 FR 55563, Aug. 16, 2023; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024]