subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "516"
part_subject: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
subpart_code: "E"
subpart_subject: "Conditionally Approved New Animal Drugs For Minor Use and Minor Species"
section_number: "516.2065"
section_subject: "Rabacfosadine."
cfr_reference: "21 CFR 516.2065"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.