21 C.F.R. § 522.158

Current through September 30, 2024
Section 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.

21 C.F.R. §522.158

88 FR 55564, Aug. 16, 2023
88 FR 55564, 8/16/2023