Document ID: FDA-2009-N-0665-0048
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Fomepizole
Posted Date: 2009-09-17T04:00Z

[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Rules and Regulations]
[Page 47725-47726]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se09-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2009-N-0665]

New Animal Drugs; 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 the original approval of an abbreviated new
animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA
provides for the veterinary prescription use of fomepizole injectable
solution as an antidote for ethylene glycol (antifreeze) poisoning in
dogs.

DATES:  This rule is effective September 17, 2009.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Synerx Pharma, LLC, 100 N. State St.,
Newtown, PA 18940-2048, filed ANADA 200-472 that provides for
veterinary prescription use of Fomepizole for Injection as an antidote
for ethylene glycol (antifreeze) poisoning in dogs. Synerx Pharma,
LLC's Fomepizole for Injection is approved as a generic copy of Paladin
Laboratories' ANTIZOL-VET (fomepizole), approved under NADA 141-075.
The ANADA is approved as of 2009, and the regulations are amended in 21
CFR 522.1004 to reflect the approval.
    In addition, Synerx Pharma, LLC, is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 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 Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

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

21 CFR Part 522

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Synerx Pharma, LLC''; and in the table in paragraph
(c)(2), numerically add an entry for ``068882'' 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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                                * * * * *
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Synerx Pharma, LLC, 100 N. State St.,         068882
 Newtown, PA 18940-2048
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                                * * * * *
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    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
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                                * * * * *
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068882                       Synerx Pharma, LLC, 100 N. State St.,
                              Newtown, PA 18940-2048
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
4. In Sec.  522.1004, revise paragraph (b) to read as follows:

Sec.  522.1004   Fomepizole.

* * * * *

[[Page 47726]]

    (b) Sponsors. See Nos. 068727 and 068882 in Sec.  510.600(c) of
this chapter.
* * * * *

    Dated: September 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-22384 Filed 9-16-09; 8:45 am]

BILLING CODE 4160-01-S