[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Rules and Regulations]
[Page 263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja07-9]
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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:
melanie.berson@fda.hhs.gov.
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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