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: "516.1684"
section_subject: "Paclitaxel."
cfr_reference: "21 CFR 516.1684"
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 60 milligrams (mg) paclitaxel. Each milliliter of constituted solution contains 1 mg paclitaxel.
(b)Sponsor. See No. 052818 in 510.600(c) of this chapter.
(c)Conditions of use in dogs—(1) Amount. Administer 150 mg per square meter of body surface area intravenously over 15 to 30 minutes, once every 3 weeks, for up to 4 doses.
(2)Indications for use. For the treatment of nonresectable stage III, IV, or V mammary carcinoma in dogs that have not received previous chemotherapy or radiotherapy. For the treatment of resectable and nonresectable squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy.
(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.