21 CFR 522.1850 - Polysulfated glycosaminoglycan.

§ 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]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS