[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55481-55482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22195]
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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.
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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: [email protected].
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
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NADA No. Trade name (drug) Applicant
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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.
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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amendments thereto, is hereby withdrawn, effective September 20, 2012.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]
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