§522.1704. Pentosan polysulfate sodium.

21 C.F.R. § 522.1704

(a)

Specifications. Each milliliter of solution contains 250 milligrams (mg) of pentosan polysulfate sodium.

(b)

Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c)

Conditions of use—

(1)

Amount. Administer 3 mg per kilogram of body weight (1.4 mg per pound) by intramuscular injection once weekly for 4 weeks for a total of four doses.

(2)

Indications for use. For the control of clinical signs associated with osteoarthritis in horses.

(3)

Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Notes, amendments, and revision history

[88 FR 16548, Mar. 20, 2023, as amended at 88 FR 84701, Dec. 6, 2023]

Authority: 21 U.S.C. 360b.

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

[88 FR 16548, Mar. 20, 2023, as amended at 88 FR 84701, Dec. 6, 2023]