
[Federal Register: May 11, 2009 (Volume 74, Number 89)]
[Rules and Regulations]               
[Page 21767-21768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my09-1]                         


========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================



[[Page 21767]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

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

 
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 original approval of a new animal drug 
application (NADA) filed by Dechra, Ltd. The NADA provides for the 
veterinary prescription use of trilostane capsules in dogs for 
treatment of pituitary-dependent hyperadrenocorticism and for treatment 
of hyperadrenocorticism due to adrenocortical tumor.

DATES: This rule is effective May 11, 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, 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 NADA 141-291 that provides for veterinary 
prescription use of VETORYL (trilostane) Capsules in dogs for treatment 
of pituitary-dependent hyperadrenocorticism and for treatment of 
hyperadrenocorticism due to adrenocortical tumor. The NADA is approved 
as of December 5, 2008, and the regulations are amended in 21 CFR part 
520 to reflect the approval.
    In addition, Dechra, Ltd. is not currently listed in the animal 
drug regulations as a sponsor of an approved application. Accordingly, 
21 CFR 510.600(c) is being amended to add entries for this sponsor.
    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 (the 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.
    Under section 573(c) of the act (21 U.S.C. 360ccc-2), the approval 
of trilostane capsules for treatment of hyperadrenocorticism due to 
adrenocortical tumor in dogs qualifies for 7 years of exclusive 
marketing rights beginning on the date of approval because the new 
animal drug has been declared a designated new animal drug by FDA under 
section 573(a) of the act.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Dechra, Ltd.''; and in the table in paragraph 
(c)(2), numerically add an entry for ``043264'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Dechra, Ltd., Dechra House, Jamage            043264
 Industrial Estate, Talke Pits, Stoke-on-
 Trent, Staffordshire, ST7 1XW, United
 Kingdom
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
043264                       Dechra, Ltd., Dechra House, Jamage
                              Industrial Estate, Talke Pits, Stoke-on-
                              Trent, Staffordshire, ST7 1XW, United
                              Kingdom
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. Add Sec.  520.2598 to read as follows:


Sec.  520.2598  Trilostane.

    (a) Specifications. Each capsule contains 30 or 60 milligrams (mg) 
trilostane.
    (b) Sponsor. See No. 043264 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. The starting dose is 1.0 
to 3.0

[[Page 21768]]

milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.
    (2) Indications for use. For treatment of pituitary-dependent 
hyperadrenocorticism. For treatment of hyperadrenocorticism due to 
adrenocortical tumor.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: May 5, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-10927 Filed 5-8-09; 8:45 am]

BILLING CODE 4160-01-S
