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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.928

§ 520.928. Firocoxib tablets.

289 words·~1 min read·/us/cfr/t21/s§ 520.928·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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]
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§ 520.928
Firocoxib tablets.
Fed. Reg.×2
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