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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0902]

Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 20, 2012.
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:

The sponsors in table 1 of this document have requested that FDA withdraw approval of the four NADAs listedbecause the products are no longer manufactured or marketed.

Table 1—Withdrawal of Approval Requests NADA No. Trade name (drug) Applicant 030-525 NUMORPHAN (oxymorphone hydrochloride) Injection Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 19317. 035-825 NARCAN (naloxone hydrochloride) Injection Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 19317. 046-822 VETOCIN (oxytocin) Injection United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 4220, Madison, WI 53711. 103-090 CHORTROPIN (chorionic gonadotropin) Injection United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 4220, Madison, WI 53711.

Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116Notice of withdrawal of approval of application(21 CFR 514.116), notice is given that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all supplements and amendments thereto, is hereby withdrawn, effective September 20, 2012.

Elsewhere in this issue of theFederal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

Dated: September 5, 2012. Bernadette Dunham, Director,Center for Veterinary Medicine.