[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Rules and Regulations]
[Pages 60307-60308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24494]
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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: [email protected].
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.
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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)(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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