Robenacoxib.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) robenacoxib. (b) Sponsor. See Nos. 058198 and 069043 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter. (ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs 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 0.91 mg per pound (2 mg/kg) by subcutaneous injection, 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 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. [80 FR 61297, Oct. 13, 2015, as amended at 82 FR 12170, Mar. 1, 2017; 91 FR 41560, July 7, 2026]