21 CFR § 520.2075 - Robenacoxib.

---
identifier: "/us/cfr/t21/s520.2075"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2075 - Robenacoxib."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2075"
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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.

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