Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 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: 72 FR 41017, July 26, 2007, unless otherwise noted.
cite as: 21 CFR 516.2980