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.
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: firstname.lastname@example.org.
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.
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 § 514.116 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that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all supplements and amendments thereto, is hereby withdrawn, effective September 20, 2012.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.
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22195 Filed 9-7-12; 8:45 am]
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