[Federal Register Volume 61, Number 181 (Tuesday, September 17, 1996)]
[Rules and Regulations]
[Pages 48829-48830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23758]


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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; 
Atipamezole

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 new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for intramuscular use of 
atipamezole hydrochloride sterile injectable solution in dogs as a 
medetomidine reversing agent.

EFFECTIVE DATE: September 17, 1996.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, has filed NADA 141-033, which provides for intramuscular use of 
Antisedan (atipamezole hydrochloride) sterile injectable 
solution in dogs as a reversing agent for Domitor 
(medetomidine). Medetomidine is a sedative and analgesic agent approved 
for use in dogs. The NADA is approved as of August 6, 1996, and the 
regulations are amended in part 522 (21 CFR part 522) by adding new 
Sec. 522.147 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning August 6, 
1996, because no active ingredient (including any ester or salt of the 
drug)

[[Page 48830]]

has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 522

    Animal drugs.
    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

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 522.147 is added to read as follows:


Sec. 522.147  Atipamezole hydrochloride.

    (a) Specifications. Each milliliter of sterile injectable solution 
contains 5.0 milligrams of atipamezole hydrochloride.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Inject intramuscularly 
the same volume as that of medetomidine used.
    (2) Indications for use. To reverse clinical effects of the 
sedative and analgesic agent medetomidine hydrochloride.
    (3) Limitations. For intramuscular use only. Not recommended for 
use in pregnant or lactating animals, or animals intended for breeding. 
Atipamezole has not been evaluated in breeding animals. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: September 4, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-23758 Filed 9-16-96; 8:45 am]
BILLING CODE 4160-01-F