21 CFR § 522.1468 - Naproxen for injection.

---
identifier: "/us/cfr/t21/s522.1468"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1468 - Naproxen for injection."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1468"
section_name: "Naproxen for injection."
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"
---


# 522.1468 Naproxen for injection.

(a) *Specifications.* The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter).

(b) *Sponsor.* See 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in horses*—(1) *Dosage.* Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days.

(2) *Indications for use.* For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse.

(3) *Limitations.* Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014]