21 CFR § 522.158 - Bedinvetmab.

(a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 30 milligrams (mg) bedinvetmab in an extractable volume of 1 milliliter.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.

(2) Indications for use. For the control of pain associated with osteoarthritis in dogs.

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

[88 FR 55564, Aug. 16, 2023]