Document ID: FDA-2010-N-0002-0051
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Changes of Sponsors; Withdrawals of Approvals of New Animal Drug Applications: Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension
Posted Date: 2010-08-27T04:00Z

[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Rules and Regulations]               
[Page 52621-52622]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au10-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 522

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Change of Sponsor; Withdrawal of Approval of 
New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and 
Toluene Capsules; Pyrantel Pamoate Suspension

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 Peptech Animal Health Pty, Ltd. to Dechra, Ltd. 
and for an abbreviated new animal drug application (ANADA) from Church 
& Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is 
removing those portions of the regulations that reflect approval of two 
other NADAs transferred from Church & Dwight Co., Inc., to Pegasus 
Laboratories, Inc., for which voluntary withdrawal of approval was 
requested after the change of sponsorship. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of these two NADAs.

DATES: This rule is effective:
    1. August 27, 2010 for 21 CFR 510.600(c), 520.2043, and 522.533.
    2. September 7, 2010 for 21 CFR 520.580.

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: Church & Dwight Co., Inc., 469 North 
Harrison St., Princeton, NJ 08543-5297, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 101-497 
and NADA 101-498 for oral capsules containing dichlorophene and 
toluene, and ANADA 200-028 for an oral suspension of pyrantel pamoate 
to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. 
Accordingly, the agency is amending the regulations in 21 CFR 520.2043 
to reflect the transfer of ownership.
    Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie 
Park, New South Wales 2113, Australia, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 141-044 
for subcutaneous implants containing deslorelin acetate to Dechra, 
Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United Kingdom. Accordingly, the agency 
is amending the regulations in 21 CFR 522.533 to reflect the transfer 
of ownership and a current format.
    Following these changes of sponsorship, Pegasus Laboratories, Inc., 
has requested that FDA withdraw approval of the two NADAs for 
dichlorophene and toluene capsules because they are no longer 
manufactured or marketed. In a notice published elsewhere in this issue 
of the Federal Register, FDA gave notice that approval of NADA 101-497 
and 101-498, and all supplements and amendments thereto, is withdrawn, 
effective September 7, 2010. As provided in the regulatory text of this 
document, the agency is amending the regulations in 21 CFR 520.580 to 
reflect these withdrawals of approval.
    Also, following these changes of sponsorship, Church & Dwight Co., 
Inc., and Peptech Animal Health Pty, Ltd., are no longer sponsors of an 
approved application. Accordingly, 21 CFR 510.600(c) is being amended 
to remove the entries for these firms.
    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

[[Page 52622]]

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 Parts 520 and 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Church & Dwight Co., Inc.'' and ``Peptech Animal Health 
Pty, Ltd.''; and in the table in paragraph (c)(2), remove the entries 
for ``010237'' and ``064288''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.580  [Amended].

0
4. In paragraph (b)(1) of Sec.  520.580, remove ``010237,''.

Sec.  520.2043  [Amended]

0
5. In paragraph (b)(2) of Sec.  520.2043, remove ``010237'' and in its 
place add ``055246''.

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

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

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

0
7. In Sec.  522.533, revise the section heading and paragraph (b), add 
paragraph (c), and remove paragraph (d) to read as follows:

Sec.  522.533  Deslorelin.

* * * * *
    (b) Sponsor. See No. 043264 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses and ponies--(1) Amount. One implant 
per mare subcutaneously in the neck.
    (2) Indications for use. For inducing ovulation within 48 hours in 
estrous mares with an ovarian follicle greater than 30 millimeters in 
diameter.
    (3) Limitations. Do not use in horses or ponies intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-21296 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S