Document ID: FDA-2009-N-0665-0067
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Change of Sponsor; Azaperone
Posted Date: 2009-12-11T05:00Z

[Federal Register: December 11, 2009 (Volume 74, Number 237)]
[Rules and Regulations]               
[Page 65689-65690]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de09-8]                         

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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; Azaperone

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) from Schering-Plough Animal Health Corp. to Janssen 
Pharmaceutica NV.

DATES:  This rule is effective December 11, 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: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred 
ownership of, and all rights and interest in, approved NADA 115-732 for 
STRESNIL (azaperone) Injection to Janssen Pharmaceutica NV, 
Turnhoutseweg 30, B-2340 Beerse, Belgium. Accordingly, the agency is 
amending the regulations in 21 CFR 522.150 to reflect the transfer of 
ownership and a current format.
    In addition, Janssen Pharmaceutica NV 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:

    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 ``Janssen Pharmaceutica NV''; and in the table in 
paragraph (c)(2), numerically add an entry for ``012578'' 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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Janssen Pharmaceutica NV, Turnhoutseweg 30,   012578
 B-2340 Beerse, Belgium
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                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
012578                       Janssen Pharmaceutica NV, Turnhoutseweg 30,
                              B-2340 Beerse, Belgium
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

* * * * *

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. Revise Sec.  522.150 to read as follows:

Sec.  522.150   Azaperone.

    (a) Specifications. Each milliliter of solution contains 40 
milligrams (mg) azaperone.
    (b) Sponsor. See No. 012578 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For control of 
aggressiveness when mixing or regrouping weanling or feeder pigs 
weighing up to 80 pounds.
    (2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep 
intramuscular injection.

[[Page 65690]]

    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 7, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29494 Filed 12-10-09; 8:45 am]

BILLING CODE 4160-01-S