21 CFR 522.1850 - Polysulfated glycosaminoglycan.
(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 -
(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.
(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.
(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).