[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Rules and Regulations]
[Pages 21767-21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10927]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Rules and
Regulations
[[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.
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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 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:
[email protected].
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
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* * * * *
Dechra, Ltd., Dechra House, Jamage 043264
Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United
Kingdom
* * * * *
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(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]
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