Document ID: FDA-2012-N-0002-0008
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Fomepizole; Change of Sponsor;Change of Sponsor Address; Change of Sponsor Name and Address
Posted Date: 2012-05-07T04:00Z

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Rules and Regulations]
[Page 26697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10892]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor; Change of Sponsor Address; 
Change of Sponsor Name and Address; Fomepizole

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor name from Bioniche 
Teoranta to Mylan Institutional, LLC; a change of sponsor for 
fomepizole injectable solution from Synerx Pharma, LLC, to Mylan 
Institutional, LLC; and a change of sponsor address for Modern 
Veterinary Therapeutics, LLC.

DATES: This rule is effective May 7, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Bioniche Teoranta, Inverin, County Galway, 
Ireland, has informed FDA that it has changed its name and address to 
Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103. Synerx 
Pharma, LLC, 100 N. State St., Newton, PA 18940, has informed FDA that 
it has transferred ownership of, and all rights and interest in, 
abbreviated new animal drug application (ANADA) 200-472 for Fomepizole 
for Injection to Mylan Institutional, LLC. Modern Veterinary 
Therapeutics, LLC, 1550 Madruga Ave., suite 329, Coral Gables, FL 
33146, has informed FDA that it has changed its address to 18001 Old 
Cutler Rd., suite 317, Miami, FL 33157. Accordingly, the Agency is 
amending the regulations in parts 510 and 522 (21 CFR parts 510 and 
522) to reflect these changes.
    Following this change of sponsorship, Synerx Pharma, LLC, is no 
longer the sponsor of an approved application. Accordingly, Sec.  
510.600 (21 CFR 510.600) is being amended to remove the entries for 
this firm.
    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.

    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), remove the 
entries for ``Bioniche Teoranta'' and ``Synerx Pharma, LLC''; revise 
the entry for ``Modern Veterinary Therapeutics, LLC''; and 
alphabetically add a new entry for ``Mylan Institutional, LLC''; and in 
the table in paragraph (c)(2), remove the entry for ``068882'' and 
revise the entries for ``015914'' and ``063286'' to read as follows:

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

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

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------
 
                                * * * * *
Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd.,        015914
 suite 317, Miami, FL 33157..................................
 
                                * * * * *
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL          063286
 61103.......................................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
015914.................................  Modern Veterinary Therapeutics,
                                          LLC, 18001 Old Cutler Rd.,
                                          suite 317, Miami, FL 33157.
 
                                * * * * *
063286.................................  Mylan Institutional, LLC, 4901
                                          Hiawatha Dr., Rockford, IL
                                          61103.
 
                                * * * * *
------------------------------------------------------------------------

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.

* * * * *
    (b) Sponsors. See Nos. 046129 and 063286 in Sec.  510.600(c) of 
this chapter.
* * * * *

    Dated: April 30, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2012-10892 Filed 5-4-12; 8:45 am]
BILLING CODE 4164-01-P