21 C.F.R. · Food and Drugs
21 C.F.R. § 516.2980

Verdinexor.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 516.2980 — Verdinexor.

§ 516.2980 Verdinexor. (a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams (mg) verdinexor. (b) Sponsor. See No. 086121 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer verdinexor tablets orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at least 72 hours between doses. If tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week with at least 72 hours between 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. [86 FR 57996, Oct. 20, 2021]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 516.2980
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The regulatory text of 21 C.F.R. § 516.2980 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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