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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 516 - New Animal Drugs for Minor Use and Minor Species |
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Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species |
§ 516.2065 - Rabacfosadine.
Latest version.
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§ 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]