Document ID: FDA-2010-N-0002-0066
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
Posted Date: 2010-09-30T04:00Z

[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Rules and Regulations]               
[Page 60307-60308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se10-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

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

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Dexmedetomidine

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 supplemental new animal drug 
application (NADA) filed by Orion Corp. The supplemental NADA provides 
for veterinary prescription use of dexmedetomidine hydrochloride 
injectable solution as a preanesthetic to general anesthesia in cats.

DATES: This rule is effective September 30, 2010.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 60308]]

Rockville, MD 20855, 240-276-8337, e-mail: melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Orion Corp., Orionintie 1, 02200 Espoo, 
Finland, filed a supplement to NADA 141-267 for DEXDOMITOR 
(dexmedetomidine hydrochloride). The supplemental NADA provides for 
veterinary prescription use of dexmedetomidine hydrochloride injectable 
solution as a preanesthetic to general anesthesia in cats. The 
supplemental application is approved as of August 16, 2010, and the 
regulations in 21 CFR 522.558 are amended 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning on the date of approval.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.558, revise paragraph (c)(2)(ii) to read as follows:

Sec.  522.558  Dexmedetomidine.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Indications for use. For use as a sedative and analgesic to 
facilitate clinical examinations, clinical procedures, minor surgical 
procedures, and minor dental procedures; and as a preanesthetic to 
general anesthesia.
* * * * *

    Dated: September 24, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-24494 Filed 9-29-10; 8:45 am]
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