21 CFR § 520.538 - Deracoxib.
(a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.
(b) Sponsors. See Nos. 013744, 058198, and 086101 in § 510.600(c) of this chapter.
(c) 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/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.
(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.
(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) 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 dental surgery.
(iii) For the control of postoperative pain and inflammation associated with orthopedic surgery.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.