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]