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Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS / § 520.928 Firocoxib tablets.

§ 520.928 Firocoxib tablets.

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

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs - (i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. 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; 84 FR 39183, Aug. 9, 2019]