(a) Specifications. Each vial of powder contains 500 milligrams (mg) tiludronate disodium. Each milliliter of constituted solution contains 20 mg tiludronate disodium.

(b) Sponsor. See No. 061133 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer a single dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous infusion.

(2) Indication for use. For the control of clinical signs associated with navicular syndrome.

(3) 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.

[79 FR 18159, Apr. 1, 2014, as amended at 82 FR 21691, May 10, 2017; 84 FR 8974, Mar. 13, 2019]