21 CFR § 522.2075Chapter I

§ 522.2075 Robenacoxib.

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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

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

Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.

Conditions of useDogsAmount.(c) —(1) —(i) 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.

Indications for use.(ii) 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.

Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CatsAmount.(2) —(i) Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.

Indications for use.(ii) 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.

Limitations.(iii) 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]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.