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 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.
This rule is effective May 11, 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, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 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:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|Dechra, Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom||043264|
|* * * * *|
(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 DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. Add § 520.2598 to read as follows:End Amendment Part
(a) Specifications. Each capsule contains 30 or 60 milligrams (mg) trilostane.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in dogs—(1) Amount. The starting dose is 1.0 to 3.0 Start Printed Page 21768milligrams 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.
Director, Center for Veterinary Medicine.
[FR Doc. E9-10927 Filed 5-8-09; 8:45 am]
BILLING CODE 4160-01-S