Title 21
SECTION 516.2065
516.2065 Rabacfosadine.
§ 516.2065 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. 086072 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. It is a violation of Federal law to use this product other than as directed in the labeling.
[82 FR 12169, Mar. 1, 2017]