Justia Regulation Tracker

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[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Rules and Regulations]               
[Page 51365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se07-12]                         

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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 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 sedative and analgesic in cats.

DATES:  This rule is effective September 7, 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: 
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 sedative and analgesic in cats. The supplemental 
application is approved as of August 15, 2007, 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.
    The agency has determined under 21 CFR 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (the 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.
    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.

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

Sec.  522.558   Dexmedetomidine.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Indications for use and 
amount. (A) For use as a sedative and analgesic to facilitate clinical 
examinations, clinical procedures, minor surgical procedures, and minor 
dental procedures, administer 375 micrograms ([mu]g) per square meter 
([sol]m\2\) of body surface area by intravenous injection or 500 
[mu]g[sol]m\2\ of body surface area by intramuscular injection.
    (B) For use as a preanesthetic to general anesthesia, administer 
125 [mu]g[sol]m\2\ of body surface area or 375 [mu]g[sol]m\2\ of body 
surface area by intramuscular injection.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 40 [mu]g/killogram by intramuscular 
injection.
    (ii) Indications for use. For use as a sedative and analgesic to 
facilitate clinical examinations, clinical procedures, minor surgical 
procedures, and minor dental procedures.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: August 28, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-17696 Filed 9-6-07; 8:45 am]

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