[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Page 66582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; Propofol 
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 Mallinckrodt Veterinary, Inc. The NADA provides for 
intravenous use of propofol injection in dogs as an anesthetic.

EFFECTIVE DATE: December 18, 1996.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1616.

SUPPLEMENTARY INFORMATION: Mallinckrodt Veterinary, Inc., 421 East 
Hawley St., Mundelein, IL 60060, filed NADA 141-070, which provides for 
intravenous use in dogs of RapinovetTM Anesthetic Injection (each 
milliliter contains 10 milligrams of propofol). The drug is used as a 
single injection to provide general anesthesia for procedures lasting 
up to 5 minutes, for induction and maintenance of general anesthesia 
using incremental doses to effect, and for induction of general 
anesthesia where maintenance is provided by inhalant anesthetics. The 
drug is limited to use by or on the order of a licensed veterinarian. 
The NADA is approved as of November 7, 1996, and the regulations are 
amended in 21 CFR part 522 by adding new Sec. 522.2005 to reflect the 
approval. The basis of approval is provided in the freedom of 
information summary.
    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.
    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 a 5-year period of marketing exclusivity beginning 
November 7, 1996, because no active ingredient (including any ester or 
salt of the active ingredient) of the drug has been approved in any 
other application 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. 522.2005 is added to read as follows:

Sec. 522.2005  Propofol injection.

    (a) Specifications. The drug is a sterile, nonpyrogenic, oil-in-
water emulsion containing 10 milligrams of propofol per milliliter.
    (b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs. (i) The drug is indicated for use 
as an anesthetic as follows: As a single injection to provide general 
anesthesia for procedures lasting up to 5 minutes; for induction and 
maintenance of general anesthesia using incremental doses to effect; 
for induction of general anesthesia where maintenance is provided by 
inhalant anesthetics.
    (ii) The drug is administered by intravenous injection as follows: 
For induction of general anesthesia without the use of preanesthetics 
the dosage is 5.5 to 7.0 milligrams per kilogram (2.5 to 3.2 milligrams 
per pound); for the maintenance of general anesthesia without the use 
of preanesthetics the dosage is 1.1 to 3.3 milligrams per kilogram (0.5 
to 1.5 milligrams per pound). The use of preanesthetic medication 
reduces propofol dose requirements.
    (iii) Adequate data concerning safe use of propofol in pregnant and 
breeding dogs have not been obtained. Doses may need adjustment for 
geriatric or debilitated patients. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: December 6, 1996.
Stephen F. Sundlof,
Center for Veterinary Medicine.
[FR Doc. 96-32069 Filed 12-17-96; 8:45 am]
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