21 CFR § 522.2075 - Robenacoxib.

---
identifier: "/us/cfr/t21/s522.2075"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.2075 - Robenacoxib."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.2075"
section_name: "Robenacoxib."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 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]