96-32069. Implantation or Injectable Dosage Form New Animal Drugs; Propofol Injection  

  • [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]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
12/18/1996
Published:
12/18/1996
Department:
Health and Human Services Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-32069
Dates:
December 18, 1996.
Pages:
66582-66582 (1 pages)
PDF File:
96-32069.pdf
CFR: (1)
21 CFR 522.2005