Document ID: FDA-2010-N-0002-0032
Agency: fda
Document Type: Rule
Title: Certain Other Dosage Form New Animal Drugs; Detomidine
Posted Date: 2010-04-23T04:00Z

[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Rules and Regulations]
[Pages 21162-21163]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2010-N-0002]

Certain Other Dosage Form New Animal Drugs; Detomidine

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 approval of a new animal drug application 
(NADA) filed by Orion Corp. The NADA provides for veterinary 
prescription use of detomidine hydrochloride oromucosal gel for 
sedation and restraint of horses.

DATES: This rule is effective April 23, 2010.

[[Page 21163]]

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: Orion Corp., Orionintie 1, 02200 Espoo, 
Finland, filed NADA 141-306 for veterinary prescription use of 
DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of 
horses. The application is approved as of March 22, 2010, and the 
regulations in 21 CFR part 529 are amended by adding new Sec.  529.536 
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), summaries of the safety and 
effectiveness data and information submitted to support approval of 
these applications 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    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 529

    Animal drugs.

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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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

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2. Add Sec.  529.536 to read as follows:

Sec.  529.536  Detomidine.

    (a) Specifications. Each milliliter of gel contains 7.6 milligrams 
(mg) of detomidine hydrochloride.
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.018 mg 
per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually.
    (2) Indications for use. For sedation and restraint.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: April 19, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-9371 Filed 4-22-10; 8:45 am]
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