Title 21

SECTION 522.1850

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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