77 FR 175 pgs. 55481-55482 - Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
Type: NOTICEVolume: 77Number: 175Pages: 55481 - 55482
Docket number: [Docket No. FDA-2012-N-0902]
FR document: [FR Doc. 2012-22195 Filed 9-7-12; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 listed because the products are no longer manufactured or marketed.
| 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 § 514.116 Notice 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that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all supplements and amendments thereto, is hereby withdrawn, effective September 20, 2012.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 the Federal 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.
[FR Doc. 2012-22195 Filed 9-7-12; 8:45 am]
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