---
kind: "section"
citation: "21 C.F.R. § 520.928"
title: "21"
number: "520.928"
heading: "Firocoxib tablets."
url: "https://uscodex.org/cfr/21/520.928"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter as follows:
  - (1) **Nos.** 000010, 013744, 055246, 055529, and 086101 for use of products described in [paragraph (a)(1)](#a-1) as in [paragraph (c)(1)](#c-1) of this section; and
  - (2) **Nos.** 000010, 055246, and 086101 for use of the product described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (c)(2)](#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.

## Notes

### Amendments

[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; 91 FR 41559, July 7, 2026]

### Authority

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

### Source

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

### Amendments

[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; 91 FR 41559, July 7, 2026]