Electronic Code of Federal Regulations

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

§522.1850   Polysulfated glycosaminoglycan.

(a) Specifications. (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.

(2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.

(b) Sponsor. See No. 010797 in §510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Horses—(i) Indications for use. For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.

(ii) Amount—(A) Intra-articular use (carpal): 250 mg once a week for 5 weeks.

(B) Intramuscular use (carpal and hock): 500 mg every 4 days for 28 days.

(iii) Limitations. Do not use in horses intended for human consumption.

(2) Dogs—(i) Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints.

(ii) Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections).

[72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009]