Skip to Content

Rule

Oral Dosage Form New Animal Drugs; Toceranib

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of toceranib phosphate tablets in dogs for treatment of recurrent, cutaneous mast cell tumors.

DATES:

This rule is effective June 18, 2009.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, email: melanie.berson@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed NADA 141-295 that provides for veterinary prescription use of PALLADIA (toceranib phosphate) Tablets in dogs for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement. The NADA is approved as of May 22, 2009, and the regulations are amended in 21 CFR part 520 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. Start Printed Page 288751061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.

FDA has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Start List of Subjects

List of Subjects in 21 CFR Part 520

End List of Subjects Start Amendment Part

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

End Amendment Part Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority Start Amendment Part

2. Add § 520.2475 to read as follows:

End Amendment Part
Toceranib.

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

(b) Sponsor. See No. 000009 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].

Start Signature

Dated: June 12, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E9-14299 Filed 6-17-09; 8:45 am]

BILLING CODE 4160-01-S