21 C.F.R. § 516.2980

Current through May 31, 2024
Section 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.

21 C.F.R. §516.2980

86 FR 57996, Oct. 20, 2021
86 FR 57996, 10/20/2021