21 C.F.R. § 520.2075

Current through October 31, 2024
Section 520.2075 - Robenacoxib
(a)Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
(b)Sponsors. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Dogs -
(i)Amount. Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Cats -
(i)Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.2075

76 FR 18648 , Apr. 5, 2011, as amended at 79 FR 10964 , Feb. 27, 2014; 81 FR 59133 , Aug. 29, 2016
81 FR 59133, 8/29/2016