Document ID: FDA-2010-N-0002-0050
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals of New Animal Drug Applications: Dichlorophene and Toluene Capsules
Posted Date: 2010-08-27T04:00Z

[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Notices]               
[Page 52768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au10-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Withdrawal of Approval of New Animal Drug Applications; 
Dichlorophene and Toluene Capsules

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of two new animal drug applications (NADAs) for use of 
dichlorophene and toluene deworming capsules for cats and dogs. In a 
final rule published elsewhere in this issue of the Federal Register, 
FDA is amending the regulations to remove portions reflecting approval 
of these NADAs.

DATES:  Withdrawal of approval is effective September 7, 2010.

FOR FURTHER INFORMATION CONTACT:  John Bartkowiak, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9079; email: 
john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd., 
Pensacola, FL 32514 has requested that FDA withdraw approval of NADA 
101-497 for TINY TIGER (dichlorophene/toluene) Worming Capsules, NADA 
101-498 for LK (dichlorophene/toluene) Worming Capsules because they 
are no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADAs 
101-497 and 101-498, and all supplements and amendments thereto, is 
hereby withdrawn, effective September 7, 2010.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of these NADAs.

    Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-21295 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S