21 CFR § 522.158Chapter I

§ 522.158 Bedinvetmab.

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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

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

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

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

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

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

[88 FR 55564, Aug. 16, 2023]

eCFR data current as of: June 10, 2026

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