§522.1850. Polysulfated glycosaminoglycan.
21 C.F.R. § 522.1850
Specifications.
Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.
Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.
Sponsor. See No. 010797 in § 510.600(c) of this chapter.
Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Conditions of use—
Horses—
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.
Amount—
Intra-articular use (carpal)— 250 mg once a week for 5 weeks.
Intramuscular use (carpal and hock)— 500 mg every 4 days for 28 days.
Limitations. Do not use in horses intended for human consumption.
Dogs—
Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints.
Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections).
Notes, amendments, and revision history
Amendments
[72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009]