Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 522.2075 - Robenacoxib.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) robenacoxib.

(b) Sponsor. See No. 058198 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]
authority: 21 U.S.C. 360b.
source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 522.2075