74 FR 116 pgs. 28874-28875 - Oral Dosage Form New Animal Drugs; Toceranib
Type: RULEVolume: 74Number: 116Pages: 28874 - 28875
Docket number: [Docket No. FDA-2009-N-0665]
FR document: [FR Doc. E9-14299 Filed 6-17-09; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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. 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.
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
1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
2. Add § 520.2475 to read as follows:
§ 520.2475 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].
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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