Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 522.2065 - Rabacfosadine.

(a) Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses.

(2) Indications for use. For the treatment of lymphoma in dogs.

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

[87 FR 10969, Feb. 28, 2022]
authority: 21 U.S.C. 360b.
source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 522.2065