[Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
[Rules and Regulations]
[Pages 5319-5320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Naltrexone Hydrochloride Injection

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 Wildlife Laboratories, Inc. The NADA provides for use 
of naltrexone hydrochloride sterile injection as an antagonist to 
carfentanil citrate immobilization in free-ranging or confined elk and 
moose (Cervidae).

EFFECTIVE DATE: February 5, 1997.

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: Wildlife Laboratories, Inc., 1401 Duff Dr., 
suite 600, Fort Collins, CO 80524, filed

[[Page 5320]]

NADA 141-074 that provides for the use of TrexonilTM Sterile 
Injection (50 milligrams of naltrexone hydrochloride per milliliter) as 
an antagonist to carfentanil citrate immobilization in free-ranging or 
confined elk and moose (Cervidae). The NADA is approved as of December 
23, 1996, and the regulations are amended in part 522 (21 CFR part 522) 
by adding new Sec. 522.1465 to reflect the approval. The drug product 
is available on a prescription basis. The basis of approval is 
discussed in the freedom of information summary.
    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 December 23, 
1996, because no active ingredient of the drug (including any ester or 
salt of the active ingredient) has been previously approved in any 
other application filed under section 512(b)(1) of the act.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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.
    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. 522.1465 is added to read as follows:

Sec. 522.1465  Naltrexone hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of naltrexone hydrochloride.
    (b) Sponsor. See 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in elk and moose--(1) Amount. 100 milligrams 
of naltrexone hydrochloride for each milligram of carfentanil citrate 
administered. One-quarter of the dose should be administered 
intravenously and three-quarters of the dose should be administered 
subcutaneously.
    (2) Indications for use. As an antagonist to carfentanil citrate 
immobilization in free-ranging or confined elk and moose (Cervidae).
    (3)  Limitations. Available data are inadequate to recommend use in 
pregnant animals. Avoid using during breeding season. Do not use in 
domestic food-producing animals. Do not use in free-ranging animals for 
45 days before or during hunting season. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

    Dated: January 28, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-2869 Filed 2-4-97; 8:45 am]
BILLING CODE 4160-01-F