21 CFR § 520.2475 - Toceranib.

---
identifier: "/us/cfr/t21/s520.2475"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2475 - Toceranib."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2475"
section_name: "Toceranib."
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: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
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. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.2475 Toceranib.

(a) *Specifications.* Each tablet contains 10, 15, or 50 milligrams (mg) toceranib as toceranib phosphate.

(b) *Sponsor.* See No. 054771 in § 510.600 of this chapter.

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* Administer an initial dose of 3.25 mg per kilogram (1.48 mg per pound) body weight, orally every other day.

(ii) *Indications for use.* For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014]