[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Page 263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


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 an original new animal drug 
application (NADA) filed by Orion Corp. The NADA provides for 
veterinary prescription use of dexmedetomidine hydrochloride injectable 
solution as a sedative, analgesic, and preanesthetic in dogs.

DATES: This rule is effective January 4, 2007.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Orion Corp., Orionintie 1, 02200 Espoo, 
Finland, filed NADA 141-267 for DEXDOMITOR (dexmedetomidine 
hydrochloride). The NADA provides for the veterinary prescription use 
of dexmedetomidine hydrochloride injectable solution as a sedative, 
analgesic, and preanesthetic in dogs. The application is approved as of 
December 1, 2006, and 21 CFR part 522 is amended by adding new Sec.  
522.558 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), 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.
    The agency has determined under Sec.  25.33(d)(1) 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 December 1, 2006.
    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 Parts 522

    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 522 is 
amended as follows:

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

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

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

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2. Add Sec.  522.558 to read as follows:


Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) dexmedetomidine hydrochloride.
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount--
(i) For use as a sedative and analgesic in dogs to facilitate clinical 
examinations, clinical procedures, minor surgical procedures, and minor 
dental procedures, administer 375 micrograms ([micro]g) per square 
meter (/m\2\) of body surface area by intravenous injection or 500 
[micro]g/m\2\ of body surface area by intramuscular injection.
    (ii) For use as a preanesthetic to general anesthesia, administer 
125 [micro]g/m\2\ of body surface area or 375 [micro]g/m\2\ of body 
surface area by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-22508 Filed 1-3-07; 8:45 am]
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