21 CFR 522.1850 - Polysulfated glycosaminoglycan.

§ 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 -

(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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

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

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017
    1. 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correcting amendments.
      This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558