[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Rules and Regulations]
[Pages 68146-68147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522


Animal Drugs, Feeds, and Related Products; Fomepizole

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 Orphan Medical, Inc. The NADA provides for intravenous 
use of fomepizole solution as an antidote for ethylene glycol poisoning 
in dogs.
EFFECTIVE DATE: December 27, 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: Orphan Medical, Inc., 13911 Ridgedale Dr., 
suite 475, Minnetonka, MN 55305, is sponsor of NADA 141-075, which 
provides for the use of Antizol-VetTM (sterile injectable 
fomepizole solution) for use as an antidote for ethylene glycol 
(antifreeze) poisoning in dogs who have ingested or are suspected of 
having ingested ethylene glycol. The drug is for veterinary 
prescription use only. The NADA is approved as of November 25, 1996, 
and the regulations are amended in part 522 (21 CFR part 522) by adding 
a new Sec. 522.1004 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    Orphan Medical, Inc., has not previously been added to the list of 
sponsors of approved applications in Sec. 510.600(c) (21 CFR 
510.600(c)). At this time, Sec. 510.600(c)(1) and (c)(2) are amended to 
include entries for the firm.
    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 (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning November 25, 1996, because 
no active ingredient (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.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Orphan Medical, Inc.,'' and in 
the table in paragraph (c)(2) by numerically adding a new entry for 
``062161'' to read as follows:

Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

                                                                        
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code         
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  *                    *                    *                    *      
                   *                    *                    *          
Orphan Medical, Inc., 13911          062161                             
 Ridgedale Dr., suite 475,                                              
 Minnetonka, MN 55305                                                   
  *                    *                    *                    *      
                   *                    *                    *          
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[[Page 68147]]

    (2) * * *

                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
062161                              Orphan Medical, Inc., 13911         
                                     Ridgedale Dr., suite 475,          
                                     Minnetonka, MN 55305.              
  *                    *                    *                    *      
                   *                    *                    *          
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. 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).

    4. New Sec. 522.1004 is added to read as follows:

Sec. 522.1004  Fomepizole.

    (a) Specifications. Two vials, one containing 1.5 grams fomepizole 
(1.5 milliliter of 1.0 gram fomepizole per milliliter sterile aqueous 
solution), and one vial containing 30 milliliters of 0.9 percent sodium 
chloride injection USP (as a diluent).
    (b) Sponsor. See 062161 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 20 milligrams per 
kilogram initially, 15 milligrams per kilogram at 12 and 24 hours, and 
5 milligrams per kilogram at 36 hours.
    (2) Indications for use. As an antidote for ethylene glycol 
(antifreeze) poisoning in dogs who have ingested or are suspected of 
having ingested ethylene glycol.
    (3) Limitations. Administer intravenously. For use by or on the 
order of a licensed veterinarian.

    Dated: December 16, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32883 Filed 12-26-96; 8:45 am]
BILLING CODE 4160-01-F