[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Notices]
[Page 19716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0078]


Withdrawal of Approval of New Animal Drug Applications; Estradiol 
Benzoate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has withdrawn approval 
of two new animal drug applications (NADAs) for a suspension implant of 
estradiol benzoate microspheres used in steers and heifers fed in 
confinement for slaughter for increased rate of weight gain and 
improved feed efficiency, and in suckling beef calves for increased 
rate of weight gain. In a final rule published elsewhere in this issue 
of the Federal Register, FDA is amending the animal drug regulations to 
remove portions reflecting approval of these NADAs.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., 
Fort Collins, CO 80524, has requested that FDA withdraw approval of 
NADA 141-040 for DURALEASE (estradiol benzoate), a suspension implant 
of estradiol benzoate microspheres used in steers and heifers fed in 
confinement for slaughter for increased rate of weight gain and 
improved feed efficiency and NADA 141-041 for CELERIN-C (estradiol 
benzoate), a similar product used in suckling beef calves for increased 
rate of weight gain. This action is requested because the products are 
no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.115, notice is given that approval of NADA 
141-040 and NADA 141-041 and all supplements and amendments thereto, 
were withdrawn as of September 29, 2006.
    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: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 07-1941 Filed 4-18-07; 8:45 am]
BILLING CODE 4160-01-S