[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) * * *
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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) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
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