Document ID: FDA-2012-N-0902-0002
Agency: fda
Document Type: Notice
Title: Withdrawal of Approvals of New Animal Drug Applications: Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
Posted Date: 2012-09-10T04:00Z

[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55481-55482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22195]

-----------------------------------------------------------------------

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

[[Page 55482]]

because the products are no longer manufactured or marketed.

                Table 1--Withdrawal of Approval Requests
------------------------------------------------------------------------
          NADA No.              Trade name (drug)         Applicant
------------------------------------------------------------------------
030-525.....................  NUMORPHAN             Endo Pharmaceuticals
                               (oxymorphone          Inc., 100 Painters
                               hydrochloride)        Dr., Chadds Ford,
                               Injection.            PA 19317.
035-825.....................  NARCAN (naloxone      Endo Pharmaceuticals
                               hydrochloride)        Inc., 100 Painters
                               Injection.            Dr., Chadds Ford,
                                                     PA 19317.
046-822.....................  VETOCIN (oxytocin)    United Vaccines, A
                               Injection.            Harlan Sprague
                                                     Dawley, Inc., Co.,
                                                     P.O. Box 4220,
                                                     Madison, WI 53711.
103-090.....................  CHORTROPIN            United Vaccines, A
                               (chorionic            Harlan Sprague
                               gonadotropin)         Dawley, Inc., Co.,
                               Injection.            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 Sec.  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]
BILLING CODE 4160-01-P