Document ID: FDA-2013-N-0825-0002
Agency: fda
Document Type: Notice
Title: New Animal Drugs: Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone; Withdrawal
Posted Date: 2013-08-23T04:00Z

[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Page 52536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20541]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0835]

Withdrawal of Approval of New Animal Drug Applications; 
Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) at the sponsors' request 
because the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective September 3, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health Corp., 65 Challenger 
Rd., 3d Floor, Ridgefield Park, NJ 07660 has requested that FDA 
withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, 
and roxarsone in 3-way, combination drug Type C medicated feeds for 
broiler chickens and NADA 098-374 for use of nicarbazin and penicillin 
in 2-way, combination drug Type C medicated feeds for broiler chickens 
because the products are no longer manufactured or marketed.
    R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518 
has requested that FDA withdraw approval of NADA 123-116 for 
Diethylcarbamazine Citrate Capsules used in dogs for the prevention of 
heartworm disease because the product is 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 NADA 
098-371, NADA 098-374, and NADA 123-116, and all supplements and 
amendments thereto, is hereby withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the withdrawal of approval of 
these applications.

    Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20541 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P