§522.2065. Rabacfosadine.
21 C.F.R. § 522.2065
Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine.
Sponsor. See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in dogs—
Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses.
Indications for use. For the treatment of lymphoma in dogs.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[87 FR 10969, Feb. 28, 2022]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[87 FR 10969, Feb. 28, 2022]