Document ID: FDA-2009-N-0665-0030
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Toceranib - Final Rule
Posted Date: 2009-06-18T04:00Z

[Federal Register: June 18, 2009 (Volume 74, Number 116)]
[Rules and Regulations]               
[Page 28874-28875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn09-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]

 
Oral Dosage Form New Animal Drugs; Toceranib

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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.

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.

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.

[[Page 28875]]

1061, 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.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
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, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Add Sec.  520.2475 to read as follows:

Sec.  520.2475  Toceranib.

    (a) Specifications. Each tablet contains 10, 15, or 50 milligrams 
(mg) toceranib as toceranib phosphate.
    (b) Sponsor. See No. 000009 in Sec.  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].

    Dated: June 12, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-14299 Filed 6-17-09; 8:45 am]

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