CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1468—Naproxen granules.

520.1468—Naproxen granules.

(a) Specifications. Naproxen granules contain 50 percent naproxen.
(b) Sponsor. No. 000856 in § 510.600(c) of this chapter.
(c) Conditions of use— (1) Horses. The drug is used 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.
(2) (i) For oral maintenance therapy following initial intravenous dosage, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as top dressing in the animal's feed for up to 14 consecutive days. The initial intravenous dosage is 5 milligrams per kilogram of body weight.
(ii) For oral dosage only, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as a top dressing in the animal's feed for up to 14 consecutive days.
(3) Not for use in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[41 FR 14188, Apr. 2, 1976, as amended at 51 FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, 1996]