07-1941. Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) has withdrawn approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement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: [e-mail].

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notice is given that approval of NADA 141-040 and NADA 141-041 and all supplements and amendments thereto, were withdrawn as of September 29, 2006.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.