CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.538—Deracoxib.

520.538—Deracoxib.

(a) Specifications. Each chewable tablet contains 25, 50, 75, or 100 milligrams (mg) deracoxib.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs— (1) Amount. Administer orally as needed, as a single daily dose based on body weight.
(i) 1 to 2 mg/kilograms (kg) (0.45 to 0.91 mg/pound (lb), for use as in paragraph (d)(2)(i) of this section.
(ii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(ii) of this section.
(2) Indications for use. (i) For the control of pain and inflammation associated with osteoarthritis.
(ii) For the control of postoperative pain and inflammation associated with orthopedic surgery in dogs weighing 4 or more pounds (1.8 kg).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008]