Document ID: FDA-2009-N-0665-0026
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor; Fomepizole
Posted Date: 2009-06-05T04:00Z

[Federal Register: June 5, 2009 (Volume 74, Number 107)]
[Rules and Regulations]               
[Page 26951-26952]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn09-5]                         

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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; Change of Sponsor; 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 a change of sponsor for a new animal drug 
application (NADA) for fomepizole solution for injection from Jazz 
Pharmaceuticals, Inc., to Paladin Labs (USA), Inc.

DATES: This rule is effective June 5, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Jazz Pharmaceuticals, Inc., 3180 Porter Dr., 
Palo Alto, CA 94304, has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 141-075 for ANTIZOL-VET 
(fomepizole) to Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101, 
Dover, DE 19904. Accordingly, the agency is amending the regulations in 
21 CFR 522.1004 to reflect the transfer of ownership.
    Following these changes of sponsorship, Jazz Pharmaceuticals, Inc., 
is no longer the sponsor of an approved application. Accordingly, 21 
CFR 510.600(c) is being amended to remove the entries for this sponsor.
    In addition, Paladin Labs (USA), Inc., 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.
    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

[[Page 26952]]

    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) remove the entry 
for ``Jazz Pharmaceuticals, Inc.'' and alphabetically add a new entry 
for ``Paladin Labs, Inc.''; and in the table in paragraph (c)(2) remove 
the entry for ``068727'' and numerically add a new entry for ``046129'' 
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
------------------------------------------------------------------------
                                * * * * *
Paladin Labs (USA), Inc., 160 Greentree Dr.,  046129
 suite 101, Dover, DE 19904
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
046129                       Paladin Labs (USA), Inc., 160 Greentree
                              Dr., suite 101, Dover, DE 19904
                                * * * * *
------------------------------------------------------------------------

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.

Sec.  522.1004  [Amended]

0
4. In paragraph (b) of Sec.  522.1004, remove ``068727'' and add in its 
place ``046129''.

    Dated: June 1, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13126 Filed 6-4-09; 8:45 am]

BILLING CODE 4160-01-S