[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Rules and Regulations]
[Page 264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja07-10]
[[Page 264]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Atipamezole
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 adds a
claim for reversal of the sedative and analgesic effects of
dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride
injectable solution for 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 a supplement to NADA 141-033 for ANTISEDAN (atipamezole
hydrochloride), an injectable solution approved for reversal of the
sedative and analgesic effects of medetomidine hydrochloride in dogs.
The supplemental NADA adds a claim for reversal of sedative and
analgesic effects of dexmedetomidine hydrochloride to labeling for
atipamezole hydrochloride injectable solution for dogs. The application
is approved as of December 1, 2006, and the regulations are amended in
21 CFR 522.147 to reflect the approval and a current format.
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 (21 U.S.C. 360b(c)(2)(F)(iii)), 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.
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. 522.147, revise the section heading and paragraphs (a) and
(c) to read as follows:
Sec. 522.147 Atipamezole.
(a) Specifications. Each milliliter of solution contains 5.0
milligrams atipamezole hydrochloride.
* * * * *
(c) Conditions of use in dogs--(1) Amount. Inject intramuscularly
the same volume as that of dexmedetomidine or medetomidine used.
(2) Indications for use. For reversal of the sedative and analgesic
effects of dexmedetomidine hydrochloride or medetomidine hydrochloride.
(3) 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. E6-22515 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S