Food and Drug Administration, HHS.
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.
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 520End 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 DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Add § 520.2475 to read as follows:End Amendment Part
(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.
Dated: June 12, 2009.
Director, Center for Veterinary Medicine.
[FR Doc. E9-14299 Filed 6-17-09; 8:45 am]
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