21 CFR § 516.2980 - Verdinexor.

---
identifier: "/us/cfr/t21/s516.2980"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.2980 - Verdinexor."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.2980"
section_name: "Verdinexor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 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]