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§ 522.158 Bedinvetmab.

21 CFR 522.158

Citation21 CFR 522.158
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 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]