Document ID: FDA-2009-N-0665-0032
Agency: fda
Document Type: Notice
Title: Oral Dosage Form New Animal Drugs: Trilostane - Final Rule
Posted Date: 2009-06-26T04:00Z

[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Rules and Regulations]
[Pages 30463-30464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15152]

=======================================================================
-----------------------------------------------------------------------

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; Trilostane

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 supplemental approval of a new animal 
drug application (NADA) filed by Dechra, Ltd. The supplemental NADA 
provides for the addition of a 10-milligram capsule size of trilostane, 
used in dogs for treatment of hyperadrenocorticism.

DATES: This rule is effective June 26, 2009.

[[Page 30464]]

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, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage 
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, 
United Kingdom, filed a supplement to NADA 141-291 that provides for 
use of VETORYL (trilostane) Capsules in dogs for treatment of 
pituitary-dependent hyperadrenocorticism and for treatment of 
hyperadrenocorticism due to adrenocortical tumors. The supplement 
provides for the use of a 10-milligram capsule size. The supplemental 
NADA is approved as of June 5, 2009, and the regulations are amended in 
21 CFR 520.2598 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.
    The agency 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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.2598  [Amended]

0
2. In paragraph (a) of Sec.  520.2598 remove ``30 or 60 milligrams'' 
and in its place add ``10, 30, or 60 milligrams''.

    Dated: June 19, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-15152 Filed 6-25-09; 8:45 am]
BILLING CODE 4160-01-S