e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

 

Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1145


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1145   Hyaluronate.

(a)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.

(2) Sponsor. See 054771 in §510.600(c).

(3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be repeated at weekly intervals for a total of three treatments.

(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b)(1) Specifications. Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium.

(2) Sponsor. See 054771 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at weekly intervals for a total of four treatments.

(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.

(2) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more weeks but not to exceed 2 injections per week for a total of 4 weeks.

(ii) Indications for use. For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.

(2) Sponsor. See 000061 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. 50 milligrams in carpal and fetlock joints.

(ii) Indications for use. For treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mild to moderate severity.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e)(1) Specifications. Each milliliter of solution contains:

(i) 10 milligrams (mg) hyaluronate sodium; or

(ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative.

(2) Sponsors. See sponsors in §510.600(c) of this chapter:

(i) No. 000010 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section.

(ii) No. 017030 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section.

(3) Conditions of use—(i) Amount. 20 mg of the product described in paragraph (e)(1)(i) of this section by intra-articular injection into the carpus or fetlock; or 40 mg of the product described in paragraph (e)(1)(i) or (e)(1)(ii) of this section by slow intravenous injection into the jugular vein. Treatment may be repeated at weekly intervals for a total of three treatments.

(ii) Indications for use. For treatment of carpal or fetlock joint dysfunction due to noninfectious synovitis associated with equine osteoarthritis.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(f)(1) Specifications. Each milliliter of sterile aqueous solution contains 11 milligrams of hyaluronate sodium.

(2) Sponsor. See 060865 in §510.600(c).

(3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock): 22 mg; larger joint (hock): 44 mg. Treatment may be repeated at weekly intervals for a total of three treatments.

(ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, Aug. 9, 2019]

Need assistance?